The following data is part of a premarket notification filed by Electro-med Health Industries, Inc. with the FDA for Steam Pak Moist Heat.
| Device ID | K832803 |
| 510k Number | K832803 |
| Device Name: | STEAM PAK MOIST HEAT |
| Classification | Pack, Heat, Moist |
| Applicant | ELECTRO-MED HEALTH INDUSTRIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | IMA |
| CFR Regulation Number | 890.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-08-18 |
| Decision Date | 1983-09-20 |