Identity
- Trade Name
- Drive FDA UDI
- Generic Name
- Push-rim manual wheelchair, non-bariatric FDA UDI
- Device Name
- Product Description PriceSmart Scout 4-Whl Sctr, Rd/Bl, 1/ea FDA UDI
- Model / Reference
- PS-SFSCOUT4 FDA UDI
- Description
- Product Description PriceSmart Scout 4-Whl Sctr, Rd/Bl, 1/ea FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00822383001708 FDA UDI
- 510(k) Number
- K082784 FDA UDI
- FDA Product Code
- IOR FDA UDI
- GMDN Term
- Push-rim manual wheelchair, non-bariatric 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: Push-rim manual wheelchair, non-bariatric
Drive by Drive Devilbiss Healthcare — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Push-rim manual wheelchair, non-bariatric.
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- RoughRider — ROUGHRIDER AMERICA LLC · Class I
- JUDITTA — ORMESA SRL · Class I
- R82 — R82 A/S · Class I
- Tech-Med — Dukal LLC · Class I
Cleared under the same submission
K082784 also covers:
- DRIVE — Drive Devilbiss Healthcare
- DRIVEMEDICAL — Drive Devilbiss Healthcare
- DRIVEMEDICAL — 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 aa24a980-8d7b-4c4b-b8e8-8e7c8d4d8185 34 fields · synced Jun 8, 2026