Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014947080

FEI Number

3014947080

Entity Name

Praegear Viet Nam Co., Ltd.

City/State/Country

Duc Hoa District Long An, VN

Establishment Address

Lot 25, Road 1, Tan Duc Industrial Zone, Duc Hoa Ha Commune, Duc Hoa District Long An 850000, VN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Tu Yu Sports instrument factory (Owner Number: 10041441)

Owner / Operator Contact Address

Lou Village, 1st Industrial Estate, Shenzhen, CN-GD 518107, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

MD4101 Runners Therapy Plantar Fasciitis Sleeve MD4100 Runners Therapy Achilles Sleeve 930 Runners Therapy Achilles Sleeve 935 Runners Therapy Plantar Fasciitis Sleeve Stealth Ankle Brace w/ Flex-Support Stays for cleats Phantom Ankle Brace w/ Straps and Flex-Support Stays Stealth Ankle Brace w/ Flex-Support Stays for Cleats MDS1118 McDavid Sport Ankle Brace 894 Sonic Ankle Brace w/ Flex-Support Stays and Figure 8 Straps 896 Laceless Cleat Ankle brace with Stirrup Stays 889 Ankle Brace Compression Cover 891 Sonic Ankle Support MDS1112 Ankle Sleeve with Wrap Support 844 Ankle Sleeve with Compression Fit 847 Ankle Stabilizer with Flexible Support Stays 854 V-Flex Ankle Brace 851 Ultra Wrap Lace Ankle Support 855 V-Flex Ankle XT Brace 845 Ankle Sleeve with Compression Wrap Support 849 Ultra Gel Lace Ankle Support SD41140 L3 ZR Ankle Brace - Left SD41140 L3 ZR Ankle Brace (Left) MD31410 Ankle Stabilizer w/ Flexible Support Stays MDS94930 Kinesio Compression Ankle Sleeve SD41160 L3 ZR Ankle Brace (Right) MD31390 Ankle Sleeve w/ Compression Wrap Support 945 Runners Therapy Iliotibial Band MD4103 Runners Therapy Iliotibial Band MDX605 Dual Layer Compression Knee Sleeves MDS1219 McDavid Sport Knee Brace with Hinges MDS1217 Knee Patella Support Wrap w/ Dual Straps MDS1216 Knee Patella support wrap MDS1214 Knee Sleeve with Open Patella 865 Knee Compression Sleeve with Open Patella Coverage 875 Ultra Knee Support with Bilateral Hinges MD30310 Phantom Knee Brace w/ Hinge 867 Knee Compression Wrap 870 Knee Stabilizer with Flexible Support Stays SD40900 Hyperlite Knee Brace w/ Hinge SD40800 NRG Knee Brace w/ Spring hinge assist technology MD30630 NRG Knee Brace w/ Spring Hinge 2090 Biologix Knee Brace SD40760 NRG Knee Over Wrap w/ Spring Hinge MD4200 Biologix Knee Brace 863 Knee/Patella Support Strap MD31130 NRG Cross Compression Knee Sleeve w/ Spring Hinge MD30590 NRG Knee Overwrap w/ Spring Hinge 864 Knee Compression Sleeve with Closed Patella Coverage 872 Knee Support with Dual Hinges 868 Knee/Patella Support Wrap with Dual Compression Strap MD31130 NRG Cross Compression Knee Sleeve MD30790 Infused Buttersoft Knee Sleeve SD40900 Phantom Knee Brace w/ Hinges MDS94970 Kinesio Compression Knee Sleeve MD10620 Cross Compression Knee Sleeve MD30610 NRG spring hinge lightweight SD41040 Jumper Knee Patella Support Band leg sleeve Bio-Logix Knee Brace Padded Sleeve Bio-Logix Knee Brace Patella Support Sleeve Bio-Logix Knee Brace Multi-Sport Sleeve Universal Knee Brace Sleeve Universal Knee Brace Sleeve w/ Hex Pad MD31230 Infused Buttersoft Elbow Sleeve 831 Elbow Compression Sleeve with Extended Coverage 820 Wrist Compression Wrap 822 Wrist Sleeve-Wrap Support 828 Tennis Elbow Support Strap 824 Wrist 3-Strap Support MDX501 Flex Fit Wrist Wraps MDX601 Dual Layer Compression Arm Sleeves MDX607 Dual Layer Compression Elbow Sleeves MDX503 Heavy Duty Wrist Wraps MDS1517 Thumb Stabilizer MDS1314 Tennis/Golf Elbow MDS1316 Elbow Sleeve with Support Strap 842 Shoulder Support with Stability Control Strap System MD31450 Tennis/Golf Elbow Strap MD30730 Infused Buttersoft Arm Sleeve MD31510 Ultra Shoulder Support w/ Stability Control MDS94950 Kinesio Compression Elbow Sleeve HyperWrap

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2012-07-24
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	2012-07-24
ILG	Stocking, Elastic	Physical Medicine	Class 1	890.3475	2012-07-24
IPM	Cover, Limb	Physical Medicine	Class 1	890.3025	2017-01-24
IOY	Support, Arm	Physical Medicine	Class 1	890.3475	2012-07-24
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2023-03-06

Official Correspondent

Jacky Lin

US Agent Details

Jason Shuppert Business: Shock Doctor Inc. dba United Sports Brand Email: mpetersen@unitedspb.com Phone: (763) 7728571

Related Public Records

Same Entity

Tu Yu Sports instrument factory

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

View Entity Profile →

Similar Registrations

Registration Number	Establishment Name	Location
3020880065	TAYCO BRACE, INC	South Bend, IN, US
3027285106	BETTERGUARDS TECHNOLOGY GMBH	Hennigsdorf Brandenburg, DE
3043364423	SAMGEN MEDICAL LLC	Cherry Hill, NJ, US
3010646683	HARNOSANDS PLASTINDUSTRI AB	Harnosand Vasternorrland, SE
3012164853	Wilsons nc Enterprice LLC	Washington, NC, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014947080. Last updated year: 2026. Please use registration number 3014947080 when referencing this establishment in official correspondence.