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R82 Kudu SIZE-2

by R82 a/S 5 variants

R82 Kudu SIZE-2 (95221116111) is a Class I device made by R82 a/S, cleared under FDA 510(k) K151492 on 20 May 2016 and listed in FDA GUDID since 12 Oct 2022 (UDI-DI 05707292831071), 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) K151492

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 Number05707292831071 UDI-DI Date12 Oct 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) from GUDID NumberK151492 Date20 May 2016IssuedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K151492 decided 20 May 2016 Active
  • FDA GUDID UDI-DI 05707292831071 listed 12 Oct 2022 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K151492
  2. Listed FDA GUDID 05707292831071

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  • Withdrawn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
Kudu SIZE-2, 95221116111
Primary DI / UDI-DI
05707292831071
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 (K151492)

and 8 more cleared under K151492

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)