The following data is part of a premarket notification filed by Raymond Industrial, Ltd. with the FDA for Personal Body Massager, Models 1605 & 1606.
| Device ID | K912822 |
| 510k Number | K912822 |
| Device Name: | PERSONAL BODY MASSAGER, MODELS 1605 & 1606 |
| Classification | Massager, Therapeutic, Electric |
| Applicant | RAYMOND INDUSTRIAL, LTD. 121 MAIN ST. Norwalk, CT 06851 |
| Contact | Robert B Gangnath |
| Correspondent | Robert B Gangnath RAYMOND INDUSTRIAL, LTD. 121 MAIN ST. Norwalk, CT 06851 |
| Product Code | ISA |
| CFR Regulation Number | 890.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-06-25 |
| Decision Date | 1992-02-11 |