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SoftHeat HP950V1

by Kaz USA, Inc.

SoftHeat HP950V1 is a Class II device made by Kaz USA, Inc., listed in FDA GUDID since 7 Jul 2016 (UDI-DI 00328785000177), 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 Number00328785000177 UDI-DI Date7 Jul 2016ListedStatusListed 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  • Withdrawn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
SoftHeat
Generic name
External electric-heating core temperature regulation system pad
Model / Ref / Catalog
HP950V1
Primary DI / UDI-DI
00328785000177
FDA product code
IRT
GMDN term
External electric-heating core temperature regulation system pad
Device class
Class II
Regulation number
890.5740
GUDID distribution status
In Commercial Distribution

Related devices

Category: External electric-heating core temperature regulation system pad

Similar devices

Other devices filed under FDA product code IRT (Pad, Heating, Powered).

Other devices from Kaz USA, Inc.

See all devices from Kaz USA, Inc. →

Properties

  • Over-the-counter
  • Premarket exempt
Other properties (13, all answered No)