The following data is part of a premarket notification filed by Sunbeam Health Division with the FDA for Health O Meter Electric Heating Pads Models Ehp2, Ehp3.
| Device ID | K962195 |
| 510k Number | K962195 |
| Device Name: | HEALTH O METER ELECTRIC HEATING PADS MODELS EHP2, EHP3 |
| Classification | Pad, Heating, Powered |
| Applicant | SUNBEAM HEALTH DIVISION 7400 WEST 100TH PLACE Bridgeview, IL 60455 |
| Contact | Frank Brichetto |
| Correspondent | Frank Brichetto SUNBEAM HEALTH DIVISION 7400 WEST 100TH PLACE Bridgeview, IL 60455 |
| Product Code | IRT |
| CFR Regulation Number | 890.5740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-06-07 |
| Decision Date | 1996-11-27 |
| Summary: | summary |