The following data is part of a premarket notification filed by Brh Medical Ltd. with the FDA for Brh-a2 Combined Ultrasound And Electric Field Stimulation (cusefs).
| Device ID | K160378 |
| 510k Number | K160378 |
| Device Name: | BRH-A2 Combined Ultrasound And Electric Field Stimulation (CUSEFS) |
| Classification | Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat |
| Applicant | BRH Medical Ltd. The Jerusalem Technological Gardens Building A, 1st Floor Jerusalem, IL 96951 |
| Contact | Kevin Bentley |
| Correspondent | Susan Goldstein-falk Kevin Bentley mdi Consultants, Inc. 55 Northern Blvd., Suite 200 Great Neck, NY 11021 |
| Product Code | IMI |
| Subsequent Product Code | GZJ |
| Subsequent Product Code | IPF |
| Subsequent Product Code | LIH |
| CFR Regulation Number | 890.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-10 |
| Decision Date | 2017-08-25 |
| Summary: | summary |