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Trulife SFC193-22-R-K34

by Trulife 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 Number00645517821870 UDI-DI Date31 Dec 2022ListedStatusListed 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  • Withdrawn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
Trulife
Generic name
Mechanical-resistance external ankle-foot prosthesis
Model / reference
SFC193-22-R-K34
Primary DI / UDI-DI
00645517821870
FDA product code
ISH
GMDN term
Mechanical-resistance external ankle-foot prosthesis
Device class
Class I
Regulation number
890.3420
GUDID distribution status
In Commercial Distribution

Related devices

Category: Mechanical-resistance external ankle-foot prosthesis

Other devices from Trulife Inc.

See all devices from Trulife Inc. →

Properties

  • Single use
  • Over-the-counter
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date

Other properties (10)

  • Supplied sterile: No
  • Sterilise before use: No
  • Implantable: No
  • Contains latex: No
  • Prescription use: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Serial number: No
  • Expiration date: No