The following data is part of a premarket notification filed by Shinsei Corp. with the FDA for Heatpac.
| Device ID | K810320 |
| 510k Number | K810320 |
| Device Name: | HEATPAC |
| Classification | Cabinet, Moist Steam |
| Applicant | SHINSEI CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | IMB |
| CFR Regulation Number | 890.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-02-06 |
| Decision Date | 1981-03-04 |