Assembly Required Distributors INV00531
by Assembly Required Distributors Inc
Assembly Required Distributors INV00531 is a bariatric wheelchair (FDA Class I; FDA product code IOR, Wheelchair, Mechanical) made by Assembly Required Distributors Inc, cleared under FDA 510(k) K973418 on 9 Oct 1997 and listed in FDA GUDID since 6 Jul 2020 (UDI-DI 00854362008439), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00854362008439 | Date6 Jul 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK973418 | Date9 Oct 1997 | StatusActive |
Official records
- AccessGUDID record 00854362008439
- FDA 510(k) database K973418
Across registries
- FDA 510(k) K973418 decided 9 Oct 1997 Active
- FDA GUDID UDI-DI 00854362008439 listed 6 Jul 2020 Listed
Timeline
- Cleared FDA 510(k) K973418
- Listed FDA GUDID 00854362008439
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Assembly Required Distributors
- Generic name
- Bariatric wheelchair, attendant/occupant-driven, rear-wheels-operated, non-collapsible
- Model / reference
- INV00531
- Primary DI / UDI-DI
- 00854362008439
- 510(k) Number
- FDA product code
- IOR
- GMDN term
- Bariatric wheelchair, attendant/occupant-driven, rear-wheels-operated, non-collapsible
- Device class
- Class I
- Regulation number
- 890.3850
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Conditional
Similar devices
Other devices filed under FDA product code IOR (Wheelchair, Mechanical).
- Manual Wheelchair (SYIV100-CA9221) by Foshan Shunkangda Medical Tech Co., Ltd
- SAFETY PLUS MODEL 501 by Safety Rehab Systems, Inc.
- THE ENDURO by Wheel Ring, Inc.
- FOLDING, WHEELCHAIR by Brownstone Trading Co.
- TREVAIR CHAIR by Patmont Motor Werks, Inc.
- ACTIVX by Adorno Rogers Technology
- MAC-MOBILE AQUATIC CHAIR by Rehamed Intl., LLC
- VOYAGEUR AND LAURENTIAN SERIES WHEELCHAIR by Invacare Corp.
- IKON 40 Manual Wheelchair by Broda Seating (Broda Lp)
- ELLIPSE 2.3 by Everest & Jennings, Inc.