Identity
- Trade Name
- Setmark Incorporated FDA UDI
- Generic Name
- Wheelchair, attendant/occupant-driven, rear-wheels-operated, collapsible FDA UDI
- Device Name
- Alum W/C 20' seat width, dark blue uph. flip up armrests,alum. side panel , w/ footrests, 300lb capacity FDA UDI
- Model / Reference
- NF-100 FDA UDI
- Description
- Alum W/C 20' seat width, dark blue uph. flip up armrests,alum. side panel , w/ footrests, 300lb capacity FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00854204008412 FDA UDI
- 510(k) Number
- K973418 FDA UDI
- FDA Product Code
- IOR FDA UDI
- GMDN Term
- Wheelchair, attendant/occupant-driven, rear-wheels-operated, collapsible 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
No
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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Category: Wheelchair, attendant/occupant-driven, rear-wheels-operated, collapsible
Setmark Incorporated by Setmark Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Wheelchair, attendant/occupant-driven, rear-wheels-operated, collapsible.
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- Invacare® MyOn™ Ultralightweight Folding Wheelchair — Invacare Corp. · Class I
Cleared under the same submission
K973418 also covers:
- Assembly Required Distributors — Assembly Required Distributors Inc
- Assembly Required Distributors — Assembly Required Distributors Inc
- Assembly Required Distributors — Assembly Required Distributors Inc
- Assembly Required Distributors — Assembly Required Distributors Inc
- Assembly Required Distributors — Assembly Required Distributors Inc
- Assembly Required Distributors — Assembly Required Distributors Inc
- Assembly Required Distributors — Assembly Required Distributors Inc
- Assembly Required Distributors — Assembly Required Distributors Inc
- Assembly Required Distributors — Assembly Required Distributors Inc
- Assembly Required Distributors — Assembly Required Distributors Inc
- Assembly Required Distributors — Assembly Required Distributors Inc
- Assembly Required Distributors — Assembly Required Distributors Inc
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
- Setmark Inc.
Sources (1)
- FDA UDI 3bbc32ce-0630-43bb-be02-296b24f8e66a 34 fields · synced Jun 8, 2026