Identity
- Trade Name
- DRIVE FDA UDI
- Generic Name
- Wheelchair back rest positioner pin FDA UDI
- Device Name
- Transport chairs/Wheelchairs Accessories Product Description ELR Set,Black,1Pair eq EA FDA UDI
- Model / Reference
- LK3JELR FDA UDI
- Description
- Transport chairs/Wheelchairs Accessories Product Description ELR Set,Black,1Pair eq EA FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00822383161266 FDA UDI
- 510(k) Number
- K082784 FDA UDI
- FDA Product Code
- IOR FDA UDI
- GMDN Term
- Wheelchair back rest positioner pin FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.3850 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Wheelchair back rest positioner pin
Drive by Drive Devilbiss Healthcare — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K082784 also covers:
- DRIVEMEDICAL — Drive Devilbiss Healthcare
- DRIVEMEDICAL — Drive Devilbiss Healthcare
- Drive — Drive Devilbiss Healthcare
- Drive — Drive Devilbiss Healthcare
- Drive — Drive Devilbiss Healthcare
- drive — Drive Devilbiss Healthcare
- drive — Drive Devilbiss Healthcare
- Bariatric Wheelchair 22" w / Detachable Desk Arm and Elevated Leg Rest — Dynarex Corp.
- DynaRide Heavy Duty Wheelchair 24"x18" Detach Desk Arm ELR — Dynarex Corp.
- DynaRide S 1 Wheelchair-18"x16" Seat w/ Detach Desk Arm FR — Dynarex Corp.
- DynaRide S 1 Wheelchair-18"x16" Seat w/ Fixed Full Arm FR — Dynarex Corp.
- DynaRide S 4 X-Lite Wheelchair 18"x16"-18 Flip Desk Arm ELR — Dynarex Corp.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Drive Devilbiss Healthcare
Sources (1)
- FDA UDI a75552ad-443f-4d4a-970b-30a660e2b497 34 fields · synced Jun 8, 2026