Identity
- Trade Name
- HEMI SMT ART LGRST COMP FTPLT FOR 16-24W FDA UDI
- Generic Name
- Wheelchair footrest/legrest FDA UDI
- Device Name
- Swing-Away Hemi Smartleg Articulating Legrests, Composite Footplates, Padded Calf Pads FDA UDI
- Model / Reference
- AHL4C FDA UDI
- Description
- Swing-Away Hemi Smartleg Articulating Legrests, Composite Footplates, Padded Calf Pads FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841447114970 FDA UDI
- FDA Product Code
- IMM FDA UDI
- GMDN Term
- Wheelchair footrest/legrest FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.3920 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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Wheelchair footrest/legrest
Hemi Smt Art Lgrst Comp Ftplt For 16-24w by Invacare Corp. — 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
- Invacare Corp.
Sources (1)
- FDA UDI 889e51b8-1f5d-4ff9-8964-b883abb5c154 34 fields · synced May 30, 2026