Smwmed, Inc.
United Statesfrom the FDA registration address FDA FEI 3046311522
- Devices
- 3
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
What Smwmed, Inc. makes
Smwmed, Inc. manufactures single-use ECG monitoring patches designed for continuous rhythm monitoring, including models with Bluetooth connectivity for data transmission.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
- Registry: GUDID
- Registry: GUDID
- Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3046311522
- DUNS number
- 118694513
- Address
- 10180 Telesis Court, Suite 155, San Diego, CA, 92121
Frequently asked questions
How many devices does Smwmed, Inc. have in the registry?
The registry currently lists 3 devices for Smwmed, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Smwmed, Inc.'s devices?
Among its 3 most recently registered devices, Smwmed, Inc. has devices listed in FDA 510(k) (1 device) and FDA GUDID (2 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Smwmed, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Smwmed, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Smwmed, Inc. in the registry?
The most recently registered devices listed for Smwmed, Inc. include SMWMED HM-15BB-AX, SMWMED HM-15BW-AX and Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX).