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Manual Wheelchair

by Jerry Medical Instrument (Shanghai) Co., Ltd. 4 variants

Ref JR202510(k) K192658

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

CE MDR 510(k)

Valid until

Not listed

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

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K192658↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number69343741002095F Basic UDI-DI 06934374100216UDI-DIDate3 Mar 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number06934374100216 UDI-DI Date22 Oct 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK192658 Date1 Apr 2020ClearedStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · 510(k) · GUDID

Trade Name
Manual Wheelchair EUDAMED
Jerry GUDID
Generic Name
Wheelchair, attendant/occupant-driven, rear-wheels-operated, collapsible
Model / Reference
JR202
Primary DI / UDI-DI
06934374100216
Basic UDI-DI
69343741002095F
Direct Marketing DI
06934374100216
510(k) Number
FDA Product Code
IOR
EMDN Code
Y122103 Push wheelchairs
GMDN Term
Wheelchair, attendant/occupant-driven, rear-wheels-operated, collapsible
Device Class
Class I
Regulation Number
890.3850
EU market of registration
Spain
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Manufacturer details

EUDAMED SRN
CN-MF-000007638
Authorised representative
MedPath GmbH DE-AR-000000087

Other devices from Jerry Medical Instrument (Shanghai) Co., Ltd.

See all devices from Jerry Medical Instrument (Shanghai) Co., Ltd. →

Properties

  • Prescription Use
  • Over-the-Counter
  • Lot / Batch Number
  • Manufacturing Date

Other properties (20)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No