Temptek T-1000 Therapeutic Cooling Unit
510(k) K891091
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK891091 | Date26 Mar 1990 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- ILO
- Device Class
- Class II
- Regulation
- 21 CFR Part 890.5720
- Advisory Committee
- Physical Medicine
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 25 Sep 2026
The Temptek T-1000 Therapeutic Cooling Unit is a water circulating device classified as a hot or cold pack. It is designed to provide therapeutic temperature regulation through the circulation of water.
This device is regulated under FDA 510(k) clearance number K891091. It is manufactured by Temptek, Inc. and is categorized under the physical medicine specialty.
Other devices from Temptek, Inc.
Questions
AI-generated answers, 25 Sep 2026
What is the primary function of the Temptek T-1000?
The Temptek T-1000 is a therapeutic cooling unit designed to provide temperature regulation for patients through the active circulation of water.
How is this device classified for regulatory purposes?
The device is classified as a water circulating hot or cold pack under the physical medicine specialty. It is regulated under FDA 510(k) clearance number K891091.
Who is the manufacturer of the T-1000 cooling unit?
The Temptek T-1000 Therapeutic Cooling Unit is manufactured by Temptek, Inc., located in Dallas, Texas.