Identity
- Trade Name
- Assembly Required Distributors FDA UDI
- Generic Name
- Bariatric walker, foldable FDA UDI
- Device Name
- Walker - folding Bariatric-- Spec: W:27-1/2'', depth: 21'', adj height: 32' - 38-1/2'' FDA UDI
- Model / Reference
- WAM1002-01 FDA UDI
- Description
- Walker - folding Bariatric-- Spec: W:27-1/2'', depth: 21'', adj height: 32' - 38-1/2'' FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00854362008040 FDA UDI
- FDA Product Code
- ITJ FDA UDI
- GMDN Term
- Bariatric walker, foldable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.3825 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: Bariatric walker, foldable
Assembly Required Distributors by Assembly Required Distributors Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bariatric walker, foldable.
- Setmark Incorporated — SETMARK INC. · Class I
- MEDACURE — MEDACURE INC · Class I
- BRYDAN MEDICAL — BRYDAN MEDICAL HOLDINGS · 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
- Assembly Required Distributors Inc
Sources (1)
- FDA UDI 0c6cf953-eb05-4286-84a1-5cff44fc9836 33 fields · synced May 30, 2026