The following data is part of a premarket notification filed by Omron Healthcare, Inc. with the FDA for Ombron Twin-head Massager Model Hm-101.
| Device ID | K935462 |
| 510k Number | K935462 |
| Device Name: | OMBRON TWIN-HEAD MASSAGER MODEL HM-101 |
| Classification | Massager, Therapeutic, Electric |
| Applicant | OMRON HEALTHCARE, INC. 300 LAKEVIEW PKWY. Vernon Hills, IL 60061 |
| Contact | Frank Brichetto |
| Correspondent | Frank Brichetto OMRON HEALTHCARE, INC. 300 LAKEVIEW PKWY. Vernon Hills, IL 60061 |
| Product Code | ISA |
| CFR Regulation Number | 890.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-11-12 |
| Decision Date | 1994-03-04 |