The following data is part of a premarket notification filed by Migun Medical Instrument Co. Ltd. with the FDA for Thermassage Energy Product, Model Hy5000.
| Device ID | K032449 |
| 510k Number | K032449 |
| Device Name: | THERMASSAGE ENERGY PRODUCT, MODEL HY5000 |
| Classification | Table, Physical Therapy, Multi Function |
| Applicant | MIGUN MEDICAL INSTRUMENT CO. LTD. 5905 FAWN LANE Cleveland, OH 44141 |
| Contact | Edward A Kroll |
| Correspondent | Edward A Kroll MIGUN MEDICAL INSTRUMENT CO. LTD. 5905 FAWN LANE Cleveland, OH 44141 |
| Product Code | JFB |
| CFR Regulation Number | 890.5880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-08-08 |
| Decision Date | 2003-10-22 |
| Summary: | summary |