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THERA Plus 64409535C

by Fourstar Group Inc.

THERA Plus 64409535C is a Class I device made by Fourstar Group Inc., listed in FDA GUDID since 9 Jun 2026 (UDI-DI 00049696508384), registry data as of 23 Oct 2026.

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

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00049696508384 UDI-DI Date9 Jun 2026ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
THERA Plus
Generic name
Knee support orthosis
Model / reference
64409535C
Primary DI / UDI-DI
00049696508384
FDA product code
ITW
GMDN term
Knee support orthosis
Device class
Class I
Regulation number
890.3475
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code ITW (Joint, Ankle, External Brace).

Other devices from Fourstar Group Inc.

See all devices from Fourstar Group Inc. →

Properties

  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (12, all answered No)