Identity
- Trade Name
- Setmark Incorporated FDA UDI
- Generic Name
- Wheelchair footrest/legrest FDA UDI
- Device Name
- L/R - PR to fit 26' width wheelchairs - w/ padded dark blue calf pad FDA UDI
- Model / Reference
- WA-176 FDA UDI
- Description
- L/R - PR to fit 26' width wheelchairs - w/ padded dark blue calf pad FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00865388000499 FDA UDI
- FDA Product Code
- KNO FDA UDI
- GMDN Term
- Wheelchair footrest/legrest FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.3910 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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Category: Wheelchair footrest/legrest
Setmark Incorporated by Setmark Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Wheelchair footrest/legrest.
- Articulating Leg Rests — Dynarex Corp. · Class I
- Assembly Required Distributors — Assembly Required Distributors Inc · Class I
- Everest & Jennings — GF Health Products, Inc · Class I
- CM Legrest (Mini), Independent Footplate Mount — Motion Concepts Inc · Class I
- Power Elevating/Articulating Calf Panel (Upper Assy) — Motion Concepts Inc · Class I
- Roscoe Medical — COMPASS HEALTH BRANDS CORP. · Class I
- Drive — Drive Devilbiss Healthcare · Class I
- MediChoice — OWENS & MINOR DISTRIBUTION, INC. · Class I
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 cd9e069e-ef78-4796-9a0d-0de43448fc6d 33 fields · synced Jun 8, 2026