Data / Medical devices / Israel / BRH Medical Ltd
BRH Medical Ltd: FDA-registered device maker in Jerusalem, Israel, 1 510(k) clearance
BRH Medical Ltd is registered with the FDA (registration 3014315574) in Jerusalem, Israel. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated August 25, 2017. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3014315574
- Address
- Building A 1st floor the Jerusalem Technology Garden, Jerusalem, Israel, 96951
- Owner or operator
- BRH Medical Ltd (10056858)
- Roles
- Manufacturer
- First device listed
- January 23, 2018
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Interferential Current Therapy | LIH | 2 | Manufacturer | accessdata.fda.gov |
| Stimulator, Muscle, Powered | IPF | 2 | Manufacturer | accessdata.fda.gov |
| Stimulator, Nerve, Transcutaneous, For Pain Relief | GZJ | 2 | Manufacturer | accessdata.fda.gov |
| Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat | IMI | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 25, 2017 | K160378 | BRH-A2 Combined Ultrasound and Electric Field Stimulation (CUSEFS) | IMI | Substantially Equivalent | Brh Medical , Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Stimulator, Muscle, Powered
- All makers of Interferential Current Therapy
- All makers of Stimulator, Nerve, Transcutaneous, For Pain Relief
- All makers of Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
Updated August 25, 2017. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.