The following data is part of a premarket notification filed by Thermowave Medical Device Corp. with the FDA for Pulsair Model Sp-1.
| Device ID | K832177 |
| 510k Number | K832177 |
| Device Name: | PULSAIR MODEL SP-1 |
| Classification | Unit, Heating, Powered |
| Applicant | THERMOWAVE MEDICAL DEVICE CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | IRQ |
| CFR Regulation Number | 890.5950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-07-06 |
| Decision Date | 1983-12-09 |