The following data is part of a premarket notification filed by Sunbeam Health Division with the FDA for Health O Meter Electric Heating Pad W/massage Model Ehp4.
Device ID | K962252 |
510k Number | K962252 |
Device Name: | HEALTH O METER ELECTRIC HEATING PAD W/MASSAGE MODEL EHP4 |
Classification | Pad, Heating, Powered |
Applicant | SUNBEAM HEALTH DIVISION 7400 WEST 100TH PLACE Bridgeview, IL 60455 |
Contact | Frank Brichettor |
Correspondent | Frank Brichettor 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 | 1996-06-12 |
Decision Date | 1996-11-25 |
Summary: | summary |