ONLYCARE INC

FDA Device Registration & Listing · Denver, CO, US · Registration 3035374295

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3035374295
FEI Number
3035374295
Entity Name
ONLYCARE INC
City/State/Country
Denver, CO, US
Establishment Address
1312 17th Street Suite 1402, Denver, CO 80202, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
ONLYCARE INC (Owner Number: 10092480)
Owner / Operator Contact Address
1312 17th Street Suite 1402, Denver, CO 80202, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

wheelchair, model: WC01,WC02,WC03,WC04,WC05,WC06,WC07,WC08,WC09,WC10 Gait trainer, model: GT01,GT02,GT03,GT04,GT05,GT06,GT07,GT08,GT09,GT10 Walking training belt, model: WB01,WB02,WB03,WB04,WB05,WB06,WB07,WB08,WB09,WB10 Red light & infrared leg therapy pad, model: US11011A, US11012B, US11013C; Beauty therapy panel device, model: US21341A,US21342B,US2221BL,US20221OTH; Red light & infrared knee therapy pad, model: US11111RIR01,US11112RIR02,US11113RIR03; Red light & infrared head therapy pad, model: US10111A, US10112B, US10113C; Red light & infrared foot therapy pad, model: US11212A, US11213B; Red light & infrared therapy gloves, model: US10612RIR, US10613A, US10614B, US10615C, US10616D; Lumbar massage pillow, model: LMP01, LMP02, LMP03, LMP04, LMP05, LMP06, LMP07, LMP08, LMP09, LMP10 Red Light Therapy Facial Wand, model: US20221PL,US20221DSL,US20221PGL; Foot massage device, model: FM01,FM02,FM03,FM04,FM05,FM06,FM07,FM08,FM09,FM10 Massage goggles, model: MY01,MY02,MY03,MY04,MY05,MY06,MY07,MY08,MY09,MY10 Neck massage, model: NM01,NM02,NM03,NM04,NM05,NM06,NM07,NM08,NM09,NM10 Red light waist & abdominal massager, model: US2221A2, US2221A3, US2221A4, US2221A5, US2221A6, US2221A7, US2221A8 Scraping device, model: SD01,SD02,SD03,SD04,SD05,SD06,SD07,SD08,SD09,SD10 Red light waist & abdominal massager, model: US2221C5, US2221C6, US2221C7, US2221D1, US2221D2, US2221D3, US2221D4 Red light waist & abdominal massager, model: US2221B7, US2221B8, US2221B9, US2221C1, US2221C2, US2221C3, US2221C4 Red light waist & abdominal massager, model: RM10721RMR,US10721RMR,US10722RMR,US10723RMR,US2221A1; Leg massage, model: LM01,LM02,LM03,LM04,LM05,LM06,LM07,LM08,LM09,LM10 Massage back cushion, model: MK01,MK02,MK03,MK04,MK05,MK06,MK07,MK08,MK09,MK10 Red light Neck device, model: US10311A, US10312B, US10313C; Cervical traction & light therapy Relaxer, model: US10311B,US10312A,US10313B; Red light Neck Massager, model: US10321W01,US10320G01; Massage gun, model: MG01,MG02,MG03,MG04,MG05,MG06,MG07,MG08,MG09,MG10 Intelligent cupping machine, model: IC01,IC02,IC03,IC04,IC05,IC06,IC07,IC08,IC09,IC10 Hand massage, model: SM01,SM02,SM03,SM04,SM05,SM06,SM07,SM08,SM09,SM10 Red light waist & abdominal massager, model: US2221D5, US2221D6, US2221D7, US2221D8, US2221D9 Back Massage, model: BM01,BM02,BM03,BM04,BM05,BM06,BM07,BM08,BM09,BM10 Head massage, model: TM01,TM02,TM03,TM04,TM05,TM06,TM07,TM08,TM09,TM10 Fascia gun, model: FG01,FG02,FG03,FG04,FG05,FG06,FG07,FG08,FG09,FG10 Massage belt, model: MB01,MB02,MB03,MB04,MB05,MB06,MB07,MB08,MB09,MB10 Red light waist & abdominal massager, model: US2221A9, US2221B1, US2221B2, US2221B3, US2221B4, US2221B5, US2221B6 Wireless lumbar massage pillow, model: WLMP01, WLMP02, WLMP03, WLMP04, WLMP05, WLMP06, WLMP07, WLMP08, WLMP09, WLMP10 retainer cleaner, model: DC01,DC02,DC03,DC04,DC05,DC06,DC07,DC08,DC09,DC10 Orthopedic neck brace, model: ON01,ON02,ON03,ON04,ON05,ON06,ON07,ON08,ON09,ON10 Orthopedic Foot and Ankle, model: OF01,OF02,OF03,OF04,OF05,OF06,OF07,OF08,OF09,OF10 Orthopedic leg guards, model: OL01,OL02,OL03,OL04,OL05,OL06,OL07,OL08,OL09,OL10 Orthopedic elbow protection, model: OE01,OE02,OE03,OE04,OE05,OE06,OE07,OE08,OE09,OE10 Arch support device, model: AS01,AS02,AS03,AS04,AS05,AS06,AS07,AS08,AS09,AS10 Orthopedic Hand Protection, model: OP01,OP02,OP03,OP04,OP05,OP06,OP07,OP08,OP09,OP10 Orthopedic shoulder protection, model: OS01,OS02,OS03,OS04,OS05,OS06,OS07,OS08,OS09,OS10 Hip joint brace, model: HJ01,HJ02,HJ03,HJ04,HJ05,HJ06,HJ07,HJ08,HJ09,HJ10 Orthopedic harness, model: OH01,OH02,OH03,OH04,OH05,OH06,OH07,OH08,OH09,OH10 Orthotic Devices, model: OD01,OD02,OD03,OD04,OD05,OD06,OD07,OD08,OD09,OD10 Gait corrector, model: GC01,GC02,GC03,GC04,GC05,GC06,GC07,GC08,GC09,GC10 Orthopedic wrist brace, model: OW01,OW02,OW03,OW04,OW05,OW06,OW07,OW08,OW09,OW10 Orthopedic knee pads, model: OK01,OK02,OK03,OK04,OK05,OK06,OK07,OK08,OK09,OK10 Sleep aid pillow, model: AP01,AP02,AP03,AP04,AP05,AP06,AP07,AP08,AP09,AP10 Cold compress for neck protection, model:CN01,CN02,CN03,CN04,CN05, CN06,CN07,CN08,CN09,CN10 ONLYCARE Migraine Relief Cap, Upgraded Odorless Migraine Ice Head Wrap, Headache Relief Hat for Migraine, model:CH01 Cold compress shoulder protection, model:CS01,CS02,CS03,CS04,CS05,CS06,CS07,CS08,CS09,CS10 Cold gel insole, model:CI01,CI02,CI03,CI04,CI05,CI06,CI07,CI08,CI09,CI10 Cold compress gel ice bag, model:CG01,CG02,CG03,CG04,CG05,CG06,CG07,CG08,CG09,CG10 Migraine Relief Cap, model: CH02,CH03,CH04,CH05,CH06,CH07,CH08,CH09,CH10 Cold compress back cushion, model: CX01, CX02, CX03, CX04, CX05, CX06, CX07, CX08, CX09, CX10 Cold compress wrist guard, model:CW01,CW02,CW03,CW04,CW05,CW06,CW07,CW08,CW09,CW10 Cold compress for foot protection, model:CF01,CF02,CF03,CF04,CF05,CF06,CF07,CF08,CF09,CF10 Cold compress eye mask, model:CE01,CE02,CE03,CE04,CE05,CE06,CE07,CE08,CE09,CE10 Cold compress seat cushion, model:CC01,CC02,CC03,CC04,CC05,CC06,CC07,CC08,CC09,CC10 Cold compress for elbow protection, model:CE01,CE02,CE03,CE04,CE05,CE06,CE07,CE08,CE09,CE10 Cold compress disposable ice pack, model:CD01,CD02,CD03,CD04,CD05,CD06,CD07,CD08,CD09,CD10 Cold compress for ankle protection, model:CA01,CA02,CA03,CA04,CA05,CA06,CA07,CA08,CA09,CA10 Cold compress for waist protection, model:CY01,CY02,CY03,CY04,CY05,CY06,CY07,CY08,CY09,CY10 Cold compress knee pads, model:CK01,CK02,CK03,CK04,CK05,CK06,CK07,CK08,CK09,CK10 Cold therapy machine: CM01,CM02,CM03,CM04,CM05,CM06,CM07,CM08,CM09,CM10 Band aid, model: BA01,BA02,BA03,BA04,BA05,BA06,BA07,BA08,BA09,BA10 kinesio tapes, model: KT01,KT02,KT03,KT04,KT05,KT06,KT07,KT08,KT09,KT10 Electric dental floss, model: ED01,ED02,ED03,ED04,ED05,ED06,ED07,ED08,ED09,ED10 Electronic cooling sticker, model:ES01,ES02,ES03,ES04,ES05,ES06,ES07,ES08,ES09,ES10 Warm Palace Treasure, model:WP01,WP02,WP03,WP04,WP05,WP06,WP07,WP08,WP09,WP10 Hot compress patch, model: HC01,HC02,HC03,HC04,HC05,HC06,HC07,HC08,HC09,HC10 Cold treatment spray, model:CT01,CT02,CT03,CT04,CT05,CT06,CT07,CT08,CT09,CT10 deaf-aid, model: DA01,DA02,DA03,DA04,DA05,DA06,DA07,DA08,DA09,DA10 Insulin refrigerated cup, model: DI01,D102,DI03,DI04,DI05,DI06,DI07,DI08,DI09,DI10 Sleep aid mattress, model: SA01,SA02,SA03,SA04,SA05,SA06,SA07,SA08,SA09,SA10 Walking support bracket, model: WK01,WK02,WK03,WK04,WK05,WK06,WK07,WK08,WK09,WK10 a cane, model: AC01,AC02,AC03,AC04,AC05,AC06,AC07,AC08,AC09,AC10

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
IMZ Holder, Crutch And Cane, Wheelchair Physical Medicine Class 1 890.3910 2025-02-06
KHY Cane, Safety Walk Physical Medicine Class 1 890.3075 2025-02-06
KYT Light, Examination, Medical, Battery Powered General Hospital Class 1 880.6350 2025-02-05
ISA Massager, Therapeutic, Electric Physical Medicine Class 1 890.5660 2025-01-13
FLG Cleaner, Ultrasonic, Medical Instrument General Hospital Class 1 880.6150 2025-02-07
FYH Splint, Extremity, Noninflatable, External, Sterile General, Plastic Surgery Class 1 878.3910 2025-02-06
HBM Headrest, Neurosurgical Neurology Class 1 882.4440 2025-02-06
IME Pack, Hot Or Cold, Reusable Physical Medicine Class 1 890.5700 2025-02-05
ILO Pack, Hot Or Cold, Water Circulating Physical Medicine Class 2 890.5720 2025-02-07
PYO Tape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc Use General Hospital Class 1 880.5240 2025-02-06
JES Floss, Dental Dental Class 1 872.6390 2025-02-06
IMD Pack, Hot Or Cold, Disposable Physical Medicine Class 1 890.5710 2025-02-05
ESD Hearing Aid, Air-Conduction, Prescription Ear, Nose, Throat Class 1 874.3300 2025-02-06
OJL Insulin Vial Protector/Holder Physical Medicine Class 1 890.5050 2025-02-06
QTV Mattress And Bed Deck Cover (Medical Purposes) General Hospital Class 1 880.6190 2025-02-06
IPR Crutch Physical Medicine Class 1 890.3150 2025-02-06

Official Correspondent

JINGZHEN HUANG

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ONLYCARE INC
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
K882164 Arthur Blank & Co., Inc. FLOSS CARD 1988-06-10
K880871 John Wagner Associates, Inc. GRABBER WARM PACK/MINI MINI HEATER/FOOT HEATER 1988-05-20
K892457 Telstar Electronics, Inc. TELSTAR MODEL 1/3 ITE HEARING AID 1989-06-06
K760996 Unitron Industries, Inc. HEARING AID (MODEL 695D, 905 & 960P) 1976-11-16
K840825 Maico Hearing Instruments, Inc. SERIES MR IN-THE-EAR CUSTOM HEARING AID 1984-03-30

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0008-2025 Young Dental Manufacturing I, LLC 1
BIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner, REF PC016, net contents 16 fl. oz., makes 16 gallons of solution.
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 3035374295. Last updated year: 2026. Please use registration number 3035374295 when referencing this establishment in official correspondence.
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