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Gymform Total ABS VDPGYCIND0132

by Well Brain International, Ltd.

Listed FDA GUDID listing, not in commercial distribution

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 Number06973698290081 UDI-DI Date26 Apr 2021ListedStatusListed GUDID: not 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  • Withdrawn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
Gymform Total ABS
Generic Name
Physical therapy transcutaneous neuromuscular electrical stimulation system
Model / Reference
VDPGYCIND0132
Primary DI / UDI-DI
06973698290081
510(k) Number
FDA Product Code
NGX
GMDN Term
Physical therapy transcutaneous neuromuscular electrical stimulation system
Device Class
Class II
Regulation Number
890.5850
GUDID distribution status
Not in Commercial Distribution
MRI Safety
MR Safe

Other devices from Well Brain International, Ltd.

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