The following data is part of a premarket notification filed by Migun Medical Instrument Co. Ltd. with the FDA for Thermassage Enegry Product, Model Hy-7000.
| Device ID | K041200 |
| 510k Number | K041200 |
| Device Name: | THERMASSAGE ENEGRY PRODUCT, MODEL HY-7000 |
| 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 |
| Subsequent Product Code | ILY |
| Subsequent Product Code | ISA |
| CFR Regulation Number | 890.5880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-05-07 |
| Decision Date | 2004-06-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B556HY7770 | K041200 | 000 |
| B556HY7000UM0 | K041200 | 000 |
| B556HY7000U0 | K041200 | 000 |
| B344HY7770 | K041200 | 000 |
| B344HY7000UM0 | K041200 | 000 |
| B344HY7000U0 | K041200 | 000 |