Tru-Cold Therapy Pak
by Tru-Eze Mfg. Co., Inc. 510(k)
Active
510(k) K800917
Overview
Tru-Eze Mfg. Co., Inc.'s TRU-COLD THERAPY PAK is a substantially equivalent medical device that provides relief for cold-related injuries, offering a unique combination of heat and cooling therapy.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK800917 | Date2 May 1980 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- IME
- Device Class
- Class I
- Regulation
- 21 CFR Part 890.5700
- Advisory Committee
- Physical Medicine
- FDA Decision
- SESE Substantially Equivalent