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R82 Multi Frame SIZE-1

by R82 a/S

R82 Multi Frame SIZE-1 (971110210) is a Class I device made by R82 a/S, cleared under FDA 510(k) K100084 on 12 Apr 2010 and listed in FDA GUDID since 12 Oct 2022 (UDI-DI 05707292607850), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K100084

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number05707292607850 UDI-DI Date12 Oct 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) from GUDID NumberK100084 Date12 Apr 2010IssuedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K100084 decided 12 Apr 2010 Active
  • FDA GUDID UDI-DI 05707292607850 listed 12 Oct 2022 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K100084
  2. Listed FDA GUDID 05707292607850

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
R82
Generic name
Push-rim manual wheelchair, non-bariatric
Model / Ref / Catalog
Multi Frame SIZE-1, 971110210
Primary DI / UDI-DI
05707292607850
510(k) Number
FDA product code
IOR
GMDN term
Push-rim manual wheelchair, non-bariatric
Device class
Class I
Regulation number
890.3850
GUDID distribution status
In Commercial Distribution

Related devices

Category: Push-rim manual wheelchair, non-bariatric

Cleared under the same submission (K100084)

and 8 more cleared under K100084

Similar devices

Other devices filed under FDA product code IOR (Wheelchair, mechanical).

Other devices from R82 a/S

See all devices from R82 a/S →

Properties

  • Serial number
  • Manufacturing date
Other properties (13, all answered No)