The following data is part of a premarket notification filed by Omron Electronics, Inc. with the FDA for Omron Travel Massager, Model Hm-01.
| Device ID | K893029 |
| 510k Number | K893029 |
| Device Name: | OMRON TRAVEL MASSAGER, MODEL HM-01 |
| Classification | Massager, Therapeutic, Electric |
| Applicant | OMRON ELECTRONICS, INC. ONE EAST COMMERCE DR. Schaumburg, IL 60173 |
| Contact | Oishi |
| Correspondent | Oishi OMRON ELECTRONICS, INC. ONE EAST COMMERCE DR. Schaumburg, IL 60173 |
| Product Code | ISA |
| CFR Regulation Number | 890.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-24 |
| Decision Date | 1989-05-31 |