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TUNG KENG Zoomer

by Tung Keng Enterprise Co., Ltd.

Ref Joy Rider

TUNG KENG Zoomer is an electric-motor-driven wheelchair (EU MDR Class I; FDA Class II; FDA product code ITI, Wheelchair, Powered) made by Tung Keng Enterprise Co., Ltd., registered in EUDAMED on 11 Jun 2026 (Basic UDI-DI 471988454JoyRider3B), cleared under FDA 510(k) K220156 on 7 Oct 2022 and listed in FDA GUDID since 18 Jan 2024 (UDI-DI 04719884540019), active as of 23 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K220156

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number471988454JoyRider3B Basic UDI-DI 04719884540019UDI-DIDate11 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04719884540019 UDI-DI Date18 Jan 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK220156 Date7 Oct 2022DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 471988454JoyRider3B registered 11 Jun 2026 Active
  • FDA 510(k) K220156 decided 7 Oct 2022 Active
  • FDA GUDID UDI-DI 04719884540019 listed 18 Jan 2024 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K220156
  2. Listed FDA GUDID 04719884540019
  3. Registered EUDAMED 471988454JoyRider3B

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Tung Keng
Generic name
Electric-motor-driven wheelchair, occupant-controlled
Device name
Electrically Powered Wheelchair
Model / reference
Joy Rider EUDAMED
Zoomer GUDID
Primary DI / UDI-DI
04719884540019
Basic UDI-DI
471988454JoyRider3B
Direct marketing DI
04719884540019
510(k) Number
FDA product code
ITI
EMDN code
Y122127 Electric wheelchairs
GMDN term
Electric-motor-driven wheelchair, occupant-controlled
Device class
Class I EUDAMED
Class II GUDID
Regulation number
890.3860
System or procedure pack
Procedure pack which is a device in itself
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
MRI safety
MR Safe

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
Joy Rider
GUDID
Zoomer
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Electric-motor-driven wheelchair, occupant-controlled

Cleared under the same submission (K220156)

Similar devices in this category

Other devices filed under ELECTRIC WHEELCHAIRS.

Other devices from Tung Keng Enterprise Co., Ltd.

See all devices from Tung Keng Enterprise Co., Ltd. →

Properties

  • Over-the-counter
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)