Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008520652

FEI Number

3008520652

Entity Name

CR UNO INDUSTRIAL CO. LTD

City/State/Country

Taichung City, Taiwan, TW

Establishment Address

No. 23, Ln 1005, Sec 1, Hemu Rd., Qing Shui District, Taichung City, Taiwan 43641, TW

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

CR UNO Industrial Co. LTD (Owner Number: 10033413)

Owner / Operator Contact Address

No. 1-23 Chou Zang Rd, Hi-Feng Li, Chin Swea, TW-TXG --, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Hex Skin Tape 439-BK-SMMD MCDAVID Level 2 Plantar Fascia Support - Black - S/M 439-BK-LGXL MCDAVID Level 2 Plantar Fascia Support - Black - L/XL MD439 Plantar Fascia Support w/ 2mm gel pad MD30510 Posture Support 512R-L MCDAVID Level 1 Elbow Sleeve / elastic - Black - Large 489R-B-M MCDAVID Level 2 Elbow Strap w/ pads - Black - Medium 482T-BS-XL MCDAVID Level 1 Deluxe Elbow Support - Black/Scarlet - XL 454R-L MCDAVID Level 3 Wrist Brace / adjustable - Left - Black - One Size 512R-M MCDAVID Level 1 Elbow Sleeve / elastic - Black - Medium 451R MCDAVID Level 1 Wrist Wrap / adjustable - Black - One Size 485R-BL-XL MCDAVID Level 2 Elbow Support w/ strap - Black - XL 482T-BS-M MCDAVID Level 1 Deluxe Elbow Support - Black/Scarlet - Medium 513R-S/M MCDAVID Level 1 Wrist Sleeve / adjustable / elastic - Black - Small/Medium 454R-R MCDAVID Level 3 Wrist Brace / adjustable - Right - Black - One Size 488R MCDAVID Level 1 Elbow Support / adjustable - Black - One Size 5130-BK-L MCDAVID Level 2 Elbow Sleeve / 4-way elastic w/ gel buttresses - Black - Large 513R-L/XL MCDAVID Level 1 Wrist Sleeve / adjustable / elastic - Black - Large/XL 482T-BS-L MCDAVID Level 1 Deluxe Elbow Support - Black/Scarlet - Large 485R-BL-S MCDAVID Level 2 Elbow Support w/ strap - Black - Small 482R-B-M MCDAVID Level 1 Elbow Sleeve--10 inch length - Black - Medium 483R-BS-XL MCDAVID Level 1 Elbow Sleeve w/ pad - Black - XL 5120R MCDAVID Level 3 Wrist Guard / adjustable - Black - One Size 483R-BS-M MCDAVID Level 1 Elbow Sleeve w/ pad - Black - Medium 485R-BL-M MCDAVID Level 2 Elbow Support w/ strap - Black - Medium 489R-B-L MCDAVID Level 2 Elbow Strap w/ pads - Black - Large 482R-B-L MCDAVID Level 1 Elbow Sleeve--10 inch length - Black - Large 5130-BK-S MCDAVID Level 2 Elbow Sleeve / 4-way elastic w/ gel buttresses - Black - Small 485R-BL-L MCDAVID Level 2 Elbow Support w/ strap - Black - Large 486R MCDAVID Level 2 Elbow Strap / adjustable - Black - One Size 512R-XL MCDAVID Level 1 Elbow Sleeve / elastic - Black - XL 452R MCDAVID Level 1 Wrist Strap / adjustable - Black - One Size 483R-BS-S MCDAVID Level 1 Elbow Sleeve w/ pad - Black - Small 483R-BS-L MCDAVID Level 1 Elbow Sleeve w/ pad - Black - Large 489R-B-S MCDAVID Level 2 Elbow Strap w/ pads - Black - Small 482T-BS-S MCDAVID Level 1 Deluxe Elbow Support - Black/Scarlet - Small 5130-BK-XL MCDAVID Level 2 Elbow Sleeve / 4-way elastic w/ gel buttresses - Black - XL 512R-S MCDAVID Level 1 Elbow Sleeve / elastic - Black - Small 5130-BK-M MCDAVID Level 2 Elbow Sleeve / 4-way elastic w/ gel buttresses - Black - Medium 482R-B-XL MCDAVID Level 1 Elbow Sleeve--10 inch length - Black - XL 482R-B-S MCDAVID Level 1 Elbow Sleeve--10 inch length - Black - Small 513R-S/M MCDAVID Level 1 Wrist Sleeve / adjustable / elastic - Black - Small/Medium 463R-B-S MCDAVID Level 1 Shoulder Wrap - Black - Small 5120-BK-SMMD MCDAVID Level 3 Wrist Guard / adjustable - Black - Small/Medium 462T-BL-M MCDAVID Level 2 Shoulder Support - Black - Regular SD135 Elbow Compression Sleeve MD512 Elbow Sleeve/elastic MD488 Elbow Support/adjustable MD463 Shoulder Wrap SD131 Elbow Strap 463R-B-M MCDAVID Level 1 Shoulder Wrap - Black - Medium MD485 Elbow Support w/ strap MD5120 Wrist Guard/adjustable 463R-B-L MCDAVID Level 1 Shoulder Wrap - Black - Large MD5130 Elbow Sleeve/4-way elastic w/ gel buttresses 513R-L/XL MCDAVID Level 1 Wrist Sleeve / adjustable / elastic - Black - Large/XL MD462 Shoulder Support 456-BK MCDAVID Wrist Support 5120-BK-LGXL MCDAVID Level 3 Wrist Guard / adjustable - Black - Large/XL MD482 Elbow Sleeve - 10" length MD489 Elbow Strap w/ pads MD456 Wrist Support MD486 Elbow Strap/adjustable MD513 Wrist Sleeve/adjustable/elastic MD483 Elbow Sleeve w/ pad 462T-BL-L MCDAVID Level 2 Shoulder Support - Black - Large MD452 Wrist Strap/adjustable MD454 Wrist Brace/adjustable MD451 Wrist Wrap/adjustable MD5136 Elbow Sleeve 4-Way Elastic MD466 Arm Trimmer-Pair MDP500 Neoprene Elbow Sleeve w/ Abrasion Patch MDS1517 Thumb Stabilizer MDP300 Wrist Support w/ Abrasion Patch MDS1322 McDavid Sport Elbow Knit Sleeve MDS1316 Elbow Sleeve with Support Strap SD40520 Shoulder Support MD30490 Reflect Infrared Recovery Compression Wrist Sleeve MD31490 Wrist Support MD30170 Reflect Infrared Recovery Compression Elbow Sleeve SD40500 Wrist Wrap MD30230 Reflect Infrared Recovery Compression Arm Sleeve MD5120 Wrist Guard / adjustable MD31950 Back Support w/ suspenders 493T-BL-L MCDAVID Level 3 Back Stabilizer - Black - Large 491R MCDAVID Level 1 Waist Trimmer - Black - One Size 493T-BL-XL MCDAVID Level 3 Back Stabilizer - Black - XL 496R-BL-L MCDAVID Level 2 Back Support w/ suspenders - Black - Large 493R-BL-REG MCDAVID Level 3 Back Stabilizer - Black - Regular 493R-BL-L MCDAVID Level 3 Back Stabilizer - Black - Large MD493 Back Stabilizer 835 Waist Trimmer SD145 Back Support MD491 Waist Trimmer 493T-BL-REG MCDAVID Level 3 Back Stabilizer - Black - Medium 493T-BL-S MCDAVID Level 3 Back Stabilizer - Black - Small 495R-BL-REG MCDAVID Level 2 Back Support - Black - Regular 496R-BL-REG MCDAVID Level 2 Back Support w/ suspenders - Black - Regular 495R-BL-L MCDAVID Level 2 Back Support - Black - Large MD498 Women's Waist Trimmer MD495 Back Support MD496 Back Support w/ suspenders SD141 Waist Trimmer MD499 Waist Trimmer with Core Support 833 Women's Waist Trimmer MDS1424 McDavid Sport Back Knit Support MDS1414 Back Support MD30510 Posture Support SD41000 Posture Support MD31330 Arch Support MD232 TRUE ICE Therapy Ankle Wrap MD234 TRUE ICE Therapy Shoulder Wrap MD231 TRUE ICE Therapy Knee/Leg Wrap MD233 TRUE ICE Therapy Elbow/Wrist Wrap MD235 TRUE ICE Therapy Back/Ribs Wrap MDS4112 McDavid Sport Knee True Ice Recovery Wrap MDS4412 McDavid Sport Back True Ice Recovery Wrap 441R-BS-XL MCDAVID Level 1 Calf Sleeve - Black - XL 479R-M MCDAVID Level 2 Neoprene Shorts w / adjustable drawstring - Black - Medium 441R-BS-M MCDAVID Level 1 Calf Sleeve - Black - Medium 479R-L MCDAVID Level 2 Neoprene Shorts w / adjustable drawstring - Black - Large 514T-L MCDAVID Level 1 Thigh Sleeve / elastic - Black - Large 441R-BS-S MCDAVID Level 1 Calf Sleeve - Black - Small MD479 Neoprene shorts w/ adjustable drawstring 472R-BS-L MCDAVID Level 1 Thigh Sleeve w/ anterior patch - Black - Large 514T-XL MCDAVID Level 1 Thigh Sleeve / elastic - Black - XL 472R-BS-M MCDAVID Level 1 Thigh Sleeve w/ anterior patch - Black - Medium MD475 Groin Wrap/adjustable MD472 Thigh Sleeve w/ anterior patch MD514 Thigh Sleeve/elastic 479R-S MCDAVID Level 2 Neoprene Shorts w / adjustable drawstring - Black - Small MD442 Shin Splint Support/adjustable 442R MCDAVID Level 2 Shin Splint Support / adjustable - Black - One Size MD478 Thigh Wrap/adjustable 471R-BS-S MCDAVID Level 1 Thigh Sleeve - Black - Small 478R MCDAVID Level 2 Thigh Wrap / adjustable - Black - One Size 472R-BS-S MCDAVID Level 1 Thigh Sleeve w/ anterior patch - Black - Small 514T-M MCDAVID Level 1 Thigh Sleeve / elastic - Black - Medium 514R-B-M MCDAVID Level 1 Thigh Sleeve / elastic - Black - Medium 479R-XXL MCDAVID Level 2 Neoprene Shorts w / adjustable drawstring - Black - 2XL 471R-BS-L MCDAVID Level 1 Thigh Sleeve - Black - Large 472R-BS-XL MCDAVID Level 1 Thigh Sleeve w/ anterior patch - Black - XL 514R-B-XL MCDAVID Level 1 Thigh Sleeve / elastic - Black - XL 514R-B-S MCDAVID Level 1 Thigh Sleeve / elastic - Black - Small MD441 Calf Sleeve 514R-B-L MCDAVID Level 1 Thigh Sleeve / elastic - Black - Large 471R-BS-M MCDAVID Level 1 Thigh Sleeve - Black - Medium 514T-S MCDAVID Level 1 Thigh Sleeve / elastic - Black - Small 479R-XL MCDAVID Level 2 Neoprene Shorts w / adjustable drawstring - Black - XL 441R-BS-L MCDAVID Level 1 Calf Sleeve - Black - Large 471R-BS-XL MCDAVID Level 1 Thigh Sleeve - Black - XL 475R-B MCDAVID Level 1 Groin Wrap / adjustable - Black - One Size MD471 Thigh Sleeve MD465 Thigh Trimmer-Pair SD40580 Calf Sleeve SD40540 Adjustable Groin Wrap MD442 Shin Splint Support MD30890 Back Support with Hot/Cold Packs 11-FIN206-1SZ MCDAVID Thermal Back Wrap - Black - One Size 11-FIN205-1SZ MCDAVID Thermal Wrap - Black - One Size 11-FIN207-1SZ MCDAVID Thermal Shoulder Wrap - Black - One Size MD207 Thermal Shoulder Wrap w/ hot-cold gel packs MD31590 Hot or Cold Wrap w/ Reusable gel pack 202T MCDAVID Ice Bag Wrap--9 inch - Black - One Size 203T MCDAVID Ice Bag Wrap--11 inch - Black - One Size MDS95090 Knee Over Wrap Brace w/ Stays 403R-BS-M MCDAVID Level 1 Knee Sleeve w/ anterior patch - Black - Medium 510R-XL MCDAVID Level 1 Knee Sleeve / elastic - Black - XL 429RX-B-XL MCDAVID Level 3 Knee Brace w/ polycentric hinges & cross straps - Black - XL 401R-BS-M MCDAVID Level 1 Knee Sleeve - Black - Medium 4195R-B-L MCDAVID Level 2 Knee Support / adjustable / cross straps - Black - Large 4193-BK MCDAVID Level 2 Iliotibial Band Support - Black - One Size 425R-BL-XL MCDAVID Level 2 Knee Support w/ stays & cross straps - Black - XL 425T-BL-XL MCDAVID Level 2 Knee Support w/ stays & cross straps - Black - XL 404R-BS-S MCDAVID Level 1 Knee Sleeve w/ anterior patch & open patella - Black - Small 401R-BS-XXL MCDAVID Level 1 Knee Sleeve - Black - 2XL 404R-BS-XL MCDAVID Level 1 Knee Sleeve w/ anterior patch & open patella - Black - XL 419R-S/M MCDAVID Level 2 Knee Support / adjustable - Black - Small/Medium 410R-BS-L MCDAVID Level 1 Knee Support w/ Sorbothane pad - Black - Large 510R-L MCDAVID Level 1 Knee Sleeve / elastic - Black - Large 510R-S MCDAVID Level 1 Knee Sleeve / elastic - Black - Small 421T-BL-M MCDAVID Level 2 Knee Support w/ stays - Black - Medium 427T-BL-S MCDAVID Level 3 Knee Brace w/ hyper-extension hinges & straps - Black - Small 421R-BL-XXL MCDAVID Level 2 Knee Support w/ stays - Black - 2XL 429RX-B-S MCDAVID Level 3 Knee Brace w/ polycentric hinges & cross straps - Black - Small 428R-BL-XXL MCDAVID Level 3 Knee Brace w/ HD polycentric hinges - Black - 2XL 402R-BS-S MCDAVID Level 1 Knee Support w/ open patella - Black - Small 410R-BS-S MCDAVID Level 1 Knee Support w/ Sorbothane pad - Black - Small 425R-BL-XXL MCDAVID Level 2 Knee Support w/ stays & cross straps - Black - 2XL 408R MCDAVID Level 1 Knee Wrap / adjustable - Black - One Size 401R-BS-XL MCDAVID Level 1 Knee Sleeve - Black - XL 510R-M MCDAVID Level 1 Knee Sleeve / elastic - Black - Medium 409R MCDAVID Level 1 Knee Wrap / adjustable w/ open patella - Black - One Size 401T-BS-M MCDAVID Level 1 Knee Sleeve - Black - Medium 421R-BL-L MCDAVID Level 2 Knee Support w/ stays - Black - Large 429R-BL-XL MCDAVID Level 3 Knee Brace w/ polycentric hinges - Black - XL 422R-L MCDAVID Level 3 Knee Brace w/ dual disk hinges - Black - Large 421T-BL-XL MCDAVID Level 2 Knee Support w/ stays - Black - XL 414R MCDAVID Level 2 Knee Strap / patella - Black - One Size 425R-BL-S MCDAVID Level 2 Knee Support w/ stays & cross straps - Black - Small 402T-BS-S MCDAVID Level 1 Knee Support w/ open patella - Black - Small 428R-BL-M MCDAVID Level 3 Knee Brace w/ HD polycentric hinges - Black - Medium 422R-S MCDAVID Level 3 Knee Brace w/ dual disk hinges - Black - Small 404R-BS-M MCDAVID Level 1 Knee Sleeve w/ anterior patch & open patella - Black - Medium 425R-BL-L MCDAVID Level 2 Knee Support w/ stays & cross straps - Black - Large 401T-BS-S MCDAVID Level 1 Knee Sleeve - Black - Small 402T-BS-M MCDAVID Level 1 Knee Support w/ open patella - Black - Medium 425T-BL-M MCDAVID Level 2 Knee Support w/ stays & cross straps - Black - Medium 427T-BL-XXL MCDAVID Level 3 Knee Brace w/ hyper-extension hinges & straps - Black - 2XL 425R-BL-M MCDAVID Level 2 Knee Support w/ stays & cross straps - Black - Medium 402T-BS-XXL MCDAVID Level 1 Knee Support w/ open patella - Black - 2XL 429R-BL-M MCDAVID Level 3 Knee Brace w/ polycentric hinges - Black - Medium 428R-BL-S MCDAVID Level 3 Knee Brace w/ HD polycentric hinges - Black - Small 403R-BS-XL MCDAVID Level 1 Knee Sleeve w/ anterior patch - Black - XL 422R-XXL MCDAVID Level 3 Knee Brace w/ dual disk hinges - Black - 2XL 414R-S MCDAVID Level 2 Knee Strap / patella - Scarlet - One Size 402T-BS-XL MCDAVID Level 1 Knee Support w/ open patella - Black - XL 414R-GR MCDAVID Level 2 Knee Strap / patella - Gray - One Size 425T-BL-XXL MCDAVID Level 2 Knee Support w/ stays & cross straps - Black - 2XL 5125R-B-XL MCDAVID Level 2 Knee Sleeve / 4-way elastic w/ gel buttress - Black - XL 425T-BL-S MCDAVID Level 2 Knee Support w/ stays & cross straps - Black - Small 429R-BL-L MCDAVID Level 3 Knee Brace w/ polycentric hinges - Black - Large 402R-BS-XXL MCDAVID Level 1 Knee Support w/ open patella - Black - 2XL 421R-BL-M MCDAVID Level 2 Knee Support w/ stays - Black - Medium 421T-BL-XXL MCDAVID Level 2 Knee Support w/ stays - Black - 2XL 4192R-S MCDAVID Level 2 Knee Support / double wrap - Black - Small 422R-XL MCDAVID Level 3 Knee Brace w/ dual disk hinges - Black - XL 401R-BS-L MCDAVID Level 1 Knee Sleeve - Black - Large 4192R-L MCDAVID Level 2 Knee Support / double wrap - Black - Large 429R-BL-S MCDAVID Level 3 Knee Brace w/ polycentric hinges - Black - Small 429RX-B-XXL MCDAVID Level 3 Knee Brace w/ polycentric hinges & cross straps - Black - 2XL 402R-BS-L MCDAVID Level 1 Knee Support w/ open patella - Black - Large 5125R-B-M MCDAVID Level 2 Knee Sleeve / 4-way elastic w/ gel buttress - Black - Medium 404R-BS-L MCDAVID Level 1 Knee Sleeve w/ anterior patch & open patella - Black - Large 404R-BS-XXL MCDAVID Level 1 Knee Sleeve w/ anterior patch & open patella - Black - 2XL 427T-BL-L MCDAVID Level 3 Knee Brace w/ hyper-extension hinges & straps - Black - Large 421T-BL-L MCDAVID Level 2 Knee Support w/ stays - Black - Large 4192R-M MCDAVID Level 2 Knee Support / double wrap - Black - Medium 403R-BS-S MCDAVID Level 1 Knee Sleeve w/ anterior patch - Black - Small 401R-BS-S MCDAVID Level 1 Knee Sleeve - Black - Small 427T-BL-M MCDAVID Level 3 Knee Brace w/ hyper-extension hinges & straps - Black - Medium 4195R-B-M MCDAVID Level 2 Knee Support / adjustable / cross straps - Black - Medium 5125R-B-L MCDAVID Level 2 Knee Sleeve / 4-way elastic w/ gel buttress - Black - Large 402T-BS-L MCDAVID Level 1 Knee Support w/ open patella - Black - Large 402R-BS-M MCDAVID Level 1 Knee Support w/ open patella - Black - Medium 414R-R MCDAVID Level 2 Knee Strap / patella - Royal - One Size 429R-BL-XXL MCDAVID Level 3 Knee Brace w/ polycentric hinges - Black - 2XL 422R-M MCDAVID Level 3 Knee Brace w/ dual disk hinges - Black - Medium 427T-BL-XL MCDAVID Level 3 Knee Brace w/ hyper-extension hinges & straps - Black - XL 403R-BS-XXL MCDAVID Level 1 Knee Sleeve w/ anterior patch - Black - 2XL 5125R-B-S MCDAVID Level 2 Knee Sleeve / 4-way elastic w/ gel buttress - Black - Small 410R-BS-M MCDAVID Level 1 Knee Support w/ Sorbothane pad - Black - Medium 429RX-B-L MCDAVID Level 3 Knee Brace w/ polycentric hinges & cross straps - Black - Large 4195R-B-S MCDAVID Level 2 Knee Support / adjustable / cross straps - Black - Small 421R-BL-S MCDAVID Level 2 Knee Support w/ stays - Black - Small 421R-BL-XL MCDAVID Level 2 Knee Support w/ stays - Black - XL 428R-BL-XL MCDAVID Level 3 Knee Brace w/ HD polycentric hinges - Black - XL 402R-BS-XL MCDAVID Level 1 Knee Support w/ open patella - Black - XL 401T-BS-XL MCDAVID Level 1 Knee Sleeve - Black - XL 403R-BS-L MCDAVID Level 1 Knee Sleeve w/ anterior patch - Black - Large 428R-BL-L MCDAVID Level 3 Knee Brace w/ HD polycentric hinges - Black - Large 421T-BL-S MCDAVID Level 2 Knee Support w/ stays - Black - Small 419R-L/XL MCDAVID Level 2 Knee Support / adjustable - Black - Large/XL 429RX-B-M MCDAVID Level 3 Knee Brace w/ polycentric hinges & cross straps - Black - Medium 410R-BS-XL MCDAVID Level 1 Knee Support w/ Sorbothane pad - Black - XL 401T-BS-XXL MCDAVID Level 1 Knee Sleeve - Black - 2XL 401T-BS-L MCDAVID Level 1 Knee Sleeve - Black - Large 425T-BL-L MCDAVID Level 2 Knee Support w/ stays & cross straps - Black - Large 5116-BK-L MCDAVID Knee Sleeve / 4-way elastic w/ gel buttress and stays - Black - Large 5116-BK-XL MCDAVID Knee Sleeve / 4-way elastic w/ gel buttes and stays - Black - XL MD410 Knee Support w/ Sorbothane pad MD401 Knee Sleeve MD5125 Knee Sleeve/4-way elastic w/ gel buttress 5116-BK-S MCDAVID Knee Sleeve / 4-way elastic w/ gel buttress and stays - Black - Small MD414 Knee Strap/patella MD404 Knee Sleeve w/ anterior patch & open patella MD429 Knee Brace w/ polycentric hinges SD181 Knee Patella Strap 5116-BK-M MCDAVID Knee Sleeve / 4-way elastic w/ gel buttress and stays - Black - Medium MD510 Knee Sleeve / elastic MD419 Knee Support/adjustable MD429 Knee Brace w/ polycentric hinges & cross straps MD428 Knee Brace w/ HD polycentric Hinges SD182 Knee Compression Sleeve w/ Open Patella MD4195 Knee Support/adjustable/cross straps MD409 Knee Wrap/adjustable w/ open patella MD5116 Knee Sleeve/4-way elastic w/ gel buttress and stays MD421 Knee Support w/ Stays SD185 Knee Support w/ Dual Wrap MD402 Knee Support w/ open patella MD403 Knee Sleeve w/ anterior patch MD425 Knee Support w/ stays & cross Straps MD4193 Illiotibial Band Support MD422 Knee Brace w/ dual disk hinges MD4192 Knee Support/double wrap MD4201 VOW Knee Wrap with Stays 884 Quick-On Knee Stabilizer with Versatile Over Wrap System & Flexible Support Stays/Straps 886 Quick-On Knee Stabilizer with Versatile Over Wrap System & Bilateral Hinges/Straps MD4205 VOW Knee Wrap with Hinges & Straps 882 Quick-On Knee Stabilizer with Versatile Over Wrap System & Flexible Support Stays MD5113 Knee Sleeve 4-Way Elastic MD4203 VOW Knee Wrap with Stays & Straps 880 Quick-On Knee Support with Versatile Over Wrap System MDX801 Dual Density Knee Support Sleeves MDS1224 McDavid Sport Knee Knit Sleeve with Gel Buttress MDS1226 McDavid Sport Knee Knit Sleeve with Buttress and Stays MDS1217 Knee Patella Support Wrap with Dual Straps MDP400 Neoprene Knee Sleeve w/ Abrasion Patch MDS1214 Knee Sleeve with Open Patella MDP420 Neoprene Dual Wrap Knee Support w/ Abrasion Patch MDS1216 Knee Sleeve with Open Patella MDS1112 Ankle Sleeve with Wrap Support MDS1217 Knee Patella Support Wrap w/ Dual Straps MD30150 Reflect Infrared Recovery Compression Knee Sleeve SD40920 Reflect Infrared Rec Comp Knee Sleeve MD30910 Neoprene Knee Support SD40460 Knee Sleeve MD31930 Plus Size Versatile Knee Over Warp w/ Stays MD95470 Knee Stabilizer Support MD95450 Knee Over Wrap Support

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2019-11-12
IQM	Splint, Temporary Training	Physical Medicine	Class 1	890.3025	2013-11-19
IPT	Orthosis, Thoracic	Physical Medicine	Class 1	890.3490	2025-12-11
IOY	Support, Arm	Physical Medicine	Class 1	890.3475	2010-11-11
IQE	Orthosis, Lumbar	Physical Medicine	Class 1	890.3490	2015-11-21
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2025-12-11
KYR	Bag, Ice	General Hospital	Class 1	880.6050	2018-08-02
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2010-08-13
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2012-09-07
IMD	Pack, Hot Or Cold, Disposable	Physical Medicine	Class 1	890.5710	2010-11-11
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	2010-11-11

Official Correspondent

No official correspondent registered.

US Agent Details

Michelle Petersen Business: Shock Doctor Inc. dba United Sports Brands Email: mpetersen@unitedspb.com Phone: (952) 7672329

Related Public Records

Same Entity

CR UNO Industrial Co. LTD

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K843874	Beiersdorf, Inc.	LEUKOPOR SURGICAL TAPE	1985-02-21
K915446	Sun Glitz Corp.	STRETCH WRAP	1992-05-06
K833120	Acme United Corp.	ONE TIME COMPOUND BENZOIN TINCTURE-	1983-12-29
K870091	Avery Intl.	IV SECUREMENT DEVICE USING PCCE THERMO. FILM	1987-02-04
K880871	John Wagner Associates, Inc.	GRABBER WARM PACK/MINI MINI HEATER/FOOT HEATER	1988-05-20

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0505-2022	Philips North America Llc	1	Infa-Therm Transport Mattress, Reference Number 989805616831 1015
Z-0506-2022	Philips North America Llc	1	Infant Heel Warmers w/strap, Reference # 989805603201 1223

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008520652. Last updated year: 2026. Please use registration number 3008520652 when referencing this establishment in official correspondence.