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Ki Focus PT

by Ki Mobility, LLC

Ki Focus PT is a wheelchair recliner (FDA Class II; FDA product code ITI, Wheelchair, Powered) made by Ki Mobility, LLC, cleared under FDA 510(k) K201869 on 5 Sep 2023 and listed in FDA GUDID since 24 Oct 2023 (UDI-DI 00850013379255), active as of 23 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 23 Oct 2026

Documents

510(k) K201869

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850013379255 UDI-DI Date24 Oct 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK201869 Date5 Sep 2023DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K201869 decided 5 Sep 2023 Active
  • FDA GUDID UDI-DI 00850013379255 listed 24 Oct 2023 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K201869
  2. Listed FDA GUDID 00850013379255

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Ki
Generic name
Wheelchair recliner, battery-powered
Model / reference
Focus PT
Primary DI / UDI-DI
00850013379255
510(k) Number
FDA product code
ITI
GMDN term
Wheelchair recliner, battery-powered
Device class
Class II
Regulation number
890.3860
GUDID distribution status
In Commercial Distribution

Related devices

Category: Wheelchair recliner, battery-powered

Similar devices

Other devices filed under FDA product code ITI (Wheelchair, Powered).

Other devices from Ki Mobility, LLC

See all devices from Ki Mobility, LLC →

Properties

  • Over-the-counter
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)