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FS-Series Wheelchair FS804LABJF3

by Foshan Dongfang Medical Equipment Manufactory (Ltd.)

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06938001014426 UDI-DI Date2 Feb 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
FS-Series Wheelchair
Generic Name
Push-rim manual wheelchair, non-bariatric
Model / Reference
FS804LABJF3
Primary DI / UDI-DI
06938001014426
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

Cleared under the same submission (K041814)

Show all (11)

Other devices from Foshan Dongfang Medical Equipment Manufactory (Ltd.)

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Properties

  • Over-the-Counter
  • Lot / Batch Number
  • Serial Number
  • Expiration Date
  • Manufacturing Date

Other properties (9)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No