Skip to content

Bits Fr Bit-4001

by Bioness Medical, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

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 Number00810188050625 UDI-DI Date10 Jul 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Bits Fr
Generic Name
Virtual-display rehabilitation system, non-supportive, home-use
Model / Reference
BIT-4001
Primary DI / UDI-DI
00810188050625
FDA Product Code
QKC
GMDN Term
Virtual-display rehabilitation system, non-supportive, home-use
Device Class
Class II
Regulation Number
890.5360
GUDID distribution status
In Commercial Distribution

Other devices from Bioness Medical, Inc.

See all devices from Bioness Medical, Inc. →

Properties

  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (10)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No