FDA Registration
Active
🇺🇸 United States
ONLYCARE INC
Reg #: 3035374295
·
FEI: 3035374295
·
Expires 2026
Products
24
Proprietary Names
122
Establishment Types
1
Classifications
24
Registration Details
- Registration Name
- ONLYCARE INC
- Registration Number
- 3035374295
- FEI Number
- 3035374295
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1312 17th Street Suite 1402
- City
- Denver
- State
- CO
- ZIP
- 80202
- Country
- US
Owner / Operator
- Firm Name
- ONLYCARE INC
- Operator Number
- 10092480
- Address
- 1312 17th Street Suite 1402
- City
- Denver
- State
- CO
- Postal Code
- 80202
- Country
- US
- Correspondent
- JINGZHEN HUANG
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Holder, Crutch And Cane, Wheelchair | IMZ | Class 1 | Physical Medicine | No | 2025-02-06 |
| Cane, Safety Walk | KHY | Class 1 | Physical Medicine | No | 2025-02-06 |
| Light, Examination, Medical, Battery Powered | KYT | Class 1 | General Hospital | No | 2025-02-05 |
| Massager, Therapeutic, Electric | ISA | Class 1 | Physical Medicine | No | 2025-01-13 |
| Cleaner, Ultrasonic, Medical Instrument | FLG | Class 1 | General Hospital | No | 2025-02-07 |
| Splint, Extremity, Noninflatable, External, Sterile | FYH | Class 1 | General, Plastic Surgery | No | 2025-02-06 |
| Headrest, Neurosurgical | HBM | Class 1 | Neurology | No | 2025-02-06 |
| Pack, Hot Or Cold, Reusable | IME | Class 1 | Physical Medicine | No | 2025-02-05 |
| Pack, Hot Or Cold, Water Circulating | ILO | Class 2 | Physical Medicine | No | 2025-02-07 |
| Tape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc Use | PYO | Class 1 | General Hospital | No | 2025-02-06 |
| Floss, Dental | JES | Class 1 | Dental | No | 2025-02-06 |
| Pack, Hot Or Cold, Disposable | IMD | Class 1 | Physical Medicine | No | 2025-02-05 |
| Hearing Aid, Air-Conduction, Prescription | ESD | Class 1 | Ear, Nose, Throat | No | 2025-02-06 |
| Insulin Vial Protector/Holder | OJL | Class 1 | Physical Medicine | No | 2025-02-06 |
| Mattress And Bed Deck Cover (Medical Purposes) | QTV | Class 1 | General Hospital | No | 2025-02-06 |
| Crutch | IPR | Class 1 | Physical Medicine | No | 2025-02-06 |
| Toothbrush, Powered | JEQ | Class 1 | Dental | No | 2025-02-06 |
| Tips And Pads, Cane, Crutch And Walker | INP | Class 1 | Physical Medicine | No | 2025-02-06 |
| Unit, Heating, Powered | IRQ | Class 1 | Physical Medicine | No | 2025-02-06 |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | HOY | Class 1 | Ophthalmic | No | 2025-02-05 |
| Cassettes, Tissue | IDZ | Class 1 | Pathology | No | 2026-01-07 |
| Kit, Screening, Urine | JXA | Class 1 | Microbiology | No | 2025-02-06 |
| Lamp, Infrared, Therapeutic Heating | ILY | Class 2 | Physical Medicine | No | 2025-02-05 |
| Bath, Sitz, Nonpowered | KTC | Class 1 | Physical Medicine | No | 2025-02-06 |
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
Electric toothbrush, model: ET01,ET02,ET03,ET04,ET05,ET06,ET07,ET08,ET09,ET10
Walking aid, model: WA01,WA02,WA03,WA04,WA05,WA06,WA07,WA08,WA09,WA10
Bedside auxiliary bar, model: HC021
Heating headband, model: HH01,HH02,HH03,HH04,HH05,HH06,HH07,HH08,HH09,HH10
Heating elbow protection, model: HZ01,HZ02,HZ03,HZ04,HZ05,HZ06,HZ07,HZ08,HZ09,HZ10
Heating gloves, model: HG01,HG02,HG03,HG04,HG05,HG06,HG07,HG08,HG09,HG10
Heated mattress, model: HM01,HM02,HM03,HM04,HM05,HM06,HM07,HM08,HM09,HM10
Heating neck protection, model: HN01,HN02,HN03,HN04,HN05,HN06,HN07,HN08,HN09,HN10
Heating pad, model: HP01,HP02,HP03,HP04,HP05,HP06,HP07,HP08,HP09,HP10
Warm handbag, model: WS01,WS02,WS03,WS04,WS05,WS06,WS07,WS08,WS09,WS10
Heating shoulder protection, model: HS01,HS02,HS03,HS04,HS05,HS06,HS07,HS08,HS09,HS10
Heated wrist guard, model: HW01,HW02,HW03,HW04,HW05,HW06,HW07,HW08,HW09,HW10
Electric insole, model: EI01,EI02,EI03,EI04,EI05,EI06,EI07,EI08,EI09,EI10
Heating foot protection, model: HF01,HF02,HF03,HF04,HF05,HF06,HF07,HF08,HF09,HF10
Heated eye mask, model:HE01,HE02,HE03,HE04,HE05,HE06,HE07,HE08,HE09,HE10
Heating knee pads, model: HK01,HK02,HK03,HK04,HK05,HK06,HK07,HK08,HK09,HK10
Heating waist protection, model: HY01,HY02,HY03,HY04,HY05,HY06,HY07,HY08,HY09,HY10
Red light therapy glasses, model: RM0221B01, US40222B02, US40222B03, US40222B04, US40222B05;
Glasses
soft cotton tissue, model:BCT01,BCT02,BCT03,BCT04,BCT05,BCT06,BCT07,BCT08,BCT09,BCT10
urine test strips, model: UT01,UT02,UT03,UT04,UT05,UT06,UT07,UT08,UT09,UT10
Red light & near infrared therapy devices, model: US1071C09, US1071C10, US1071C11, US1071C12
Red light & infrared therapy pad, model: US11325C01,US11336D01
7 color LED Facial Mask plastic, model: RV20221MJ, RV20222A, RV20223B, RV20224C, RV20225D;
Red light & near infrared therapy devices, model:US21341RBR,US21341RBB US11342L,US10313B,US11343XP,US1071A01,US1071A02,
Red light & far infrared therapy devices, model: US11341FIR, US11342A, US11343B, US11344C, US11345D;
Red light & infrared therapy gloves, model: US10613A01,US10624B01,US20635C01,US20656D01,US10614RIR;
Red light & infrared therapy neck pillow, model: US-ZT-RI01,US10312A,US10313B;
7 color LED Facial Mask silicone with neck, model: RV20232RGB;
Red light & infrared therapy bulb, model: SR-54W,US11342S,US11343,US11343WS;
Red light & near infrared therapy devices, model:US1071C03, US1071C04, US1071C05, US1071C06, US1071C07, US1071C08
Red light & near infrared therapy devices, model: US1071A09, US1071B01, US1071B02, US1071B03, US1071B04, US1071B05
Red light & infrared therapy pad, model: US11311RIR,US11211RIR, US11412RIRBK,US11412RIRBE,US11313A01,US11314B01;
Red light & infrared therapy panel, model: US11341RIR;
Handheld Red Light Therapy Device Pro, model: US11344A01, US11344A02, US11344A03, US11344A04, US11344A05;
7 color LED Facial Mask, model:MJ01,MJ02,MJ03,MJ04,MJ05,MJ06,MJ07,MJ08.MJO9.MJ10,MJ11,MJ12,MJ13,MJ14.MJ15.MJ16
7 color LED Facial Mask silicone, model: RV20233RGB;
Red light & near infrared therapy devices, model: US11322A01,US11343B01,US11341RIRG,US11341RIRR,US11341RIRY,US11341RIRB;
Red light therapy belt, model: US10714RIRPK,US10714RIRPE,US10714RIRBL,US10714RIRPKP,US10714RIRPEP,US10714RIRBLP;
Red light & near infrared therapy devices, model: US1071A03, US1071A04, US1071A05, US1071A06, US1071A07, US1071A08
Red light & infrared therapy massager, model: RM10721RMR, RM10722A, RM10723B, RM10724C, RM10725D;
7 color LED neck Mask silicone, model: RV20331RGB;
Red light & near infrared therapy devices, model: US1071B06, US1071B07, US1071B08, US1071B09, US1071C01, US1071C02
Ice bath bucket, model: CB01,CB02,CB03,CB04,CB05,CB06,CB07,CB08,CB09,CB10
Establishment Types
Manufacture Medical Device