Thermassage Energy Product, Model HY5000
by Migun Medical Instrument Co., Ltd.
510(k) K032449
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK032449 | Date22 Oct 2003 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- JFB
- FDA applicant
- Migun Medical Instrument Co. , Ltd.
- Device Class
- Class II
- Regulation
- 21 CFR Part 890.5880
- Advisory Committee
- Physical Medicine
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 22 Sep 2026
The Thermassage Energy Product, Model HY5000 is a multi-function physical therapy table. It is intended to provide patients with muscle relaxation therapy by delivering heat and soothing massage.
This device is classified as an FDA class 2 medical device under regulation number 890.5880. It received FDA 510(k) clearance on October 22, 2003, under the product code JFB.
Other devices from Migun Medical Instrument Co., Ltd.
Questions
AI-generated answers, 22 Sep 2026
What is the primary purpose of the Thermassage Energy Product HY5000?
The HY5000 is a multi-function physical therapy table intended to provide patients with muscle relaxation therapy. It achieves this by delivering a combination of soothing massage and heat to the user.
How is this device classified for regulatory purposes?
The Thermassage Energy Product HY5000 is classified as an FDA class 2 medical device under regulation number 890.5880. It received FDA 510(k) clearance on October 22, 2003, under product code JFB.
Who is the manufacturer of the HY5000 therapy table?
The device is manufactured by Migun Medical Instrument Co., Ltd., which is based in Cleveland, Ohio.