Identity
- Trade Name
- Assembly Required Distributors FDA UDI
- Generic Name
- Wheelchair, attendant/occupant-driven, rear-wheels-operated, collapsible FDA UDI
- Device Name
- WC 18" seat width, 16" seat depth, flip-up arm,detachable footrests, w/ black/gray nylon open weave seat and back, plastic a/r 250lb capacity INV01426 FDA UDI
- Model / Reference
- INV00794 FDA UDI
- Description
- WC 18" seat width, 16" seat depth, flip-up arm,detachable footrests, w/ black/gray nylon open weave seat and back, plastic a/r 250lb capacity INV01426 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00854362008415 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
Category: Wheelchair, attendant/occupant-driven, rear-wheels-operated, collapsible
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 Wheelchair, attendant/occupant-driven, rear-wheels-operated, collapsible.
- DynaRide Reclining Wheelchair 16"x16" Detach Desk Arm ELR — Dynarex Corp. · Class I
- DynaRide S 2 Wheelchair-18"x16" Seat w/ Detach Full Arm ELR — Dynarex Corp. · Class I
- DynaRide S 2 Wheelchair-18"x16" Seat w/ Detach Desk Arm FR — Dynarex Corp. · Class I
- Everest & Jennings — GF Health Products, Inc · Class I
- Invacare® Single Density Cushion — Invacare Corp. · Class I
- Invacare® Comfort-Mate Extra Cushion — Invacare Corp. · Class I
- Invacare® Comfort-Mate Extra Cushion — Invacare Corp. · Class I
- 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Assembly Required Distributors Inc
Sources (1)
- FDA UDI 9d6c685b-9c50-45e4-9e1d-9ff5b3967c33 34 fields · synced May 30, 2026