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 |