The following data is part of a premarket notification filed by Bernlit Enterprises, Inc. with the FDA for Thermamed Bath.
| Device ID | K833631 |
| 510k Number | K833631 |
| Device Name: | THERMAMED BATH |
| Classification | Bath, Paraffin |
| Applicant | BERNLIT ENTERPRISES, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | IMC |
| CFR Regulation Number | 890.5110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-10-17 |
| Decision Date | 1983-11-28 |