The following data is part of a premarket notification filed by North American Philips Corp. with the FDA for Norelco Massager Plus Heat Belt.
| Device ID | K811891 |
| 510k Number | K811891 |
| Device Name: | NORELCO MASSAGER PLUS HEAT BELT |
| Classification | Massager, Therapeutic, Electric |
| Applicant | NORTH AMERICAN PHILIPS CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | ISA |
| CFR Regulation Number | 890.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-07-01 |
| Decision Date | 1981-07-20 |