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Bighorn Ice Plus Compression TRU-X102

by Trumedx LLC

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 Number00810175660318 UDI-DI Date11 Aug 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  • Withdrawn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
Bighorn Ice Plus Compression
Generic Name
Intermittent venous compression system
Model / Reference
TRU-X102
Description
BigHorn Ice Plus is a battery-powered cold therapy solution enhanced with pneumatic compression so you can recover fast without being tied to a wall outlet.
Primary DI / UDI-DI
00810175660318
510(k) Number
FDA Product Code
IRP
GMDN Term
Intermittent venous compression system
Device Class
Class II
Regulation Number
890.5650
GUDID distribution status
In Commercial Distribution

Other devices from Trumedx LLC

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Properties

  • Lot / Batch Number
  • Manufacturing Date

Other properties (12)

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