Thermo Trim
by Suntec Health & Fitness Group, Inc.
510(k) K852637
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK852637 | Date20 Nov 1985 | 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- Withdrawn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
- IRT
- Device Class
- Class II
- Regulation
- 21 CFR Part 890.5740
- Advisory Committee
- Physical Medicine
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Thermo Trim is classified as an Infrared Radiant Heating Device (Product Code IRT), designed to emit infrared radiation for therapeutic applications. It is intended to provide localized heat therapy to promote blood circulation, muscle relaxation, and pain relief in physical medicine settings. The device operates by converting electrical energy into infrared radiation, which penetrates tissue to deliver deep heat without direct contact.
This device is supplied as a reusable medical instrument and requires FDA 510(k) clearance (K852637) under the Traditional review pathway. It was authorized for use in 1985 and is intended for use in clinical environments where controlled heat therapy is administered. No specific sterility or MRI safety information is provided in the regulatory data, and its dimensions or storage requirements are not detailed in the available specifications.