Saratoga Intl., Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Saratoga Intl., Inc. makes
Saratoga Intl., Inc. manufactures transcutaneous electrical nerve stimulation (TENS) devices, which deliver low-voltage electrical currents to the skin for pain management. Their portfolio also includes electrotherapy systems designed for muscle stimulation and nerve modulation.
These devices fall under FDA Class II regulation and are authorised via the 510(k) pathway. The company is based in the United States.
Catalogue
Ems Ref K931401
Regimes: 510(k) Registry: 510(k)Transcutaneous Electrical Nerve Stimulation Ref K896787
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Saratoga Intl., Inc. have in the registry?
The registry currently lists 2 devices for Saratoga Intl., Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Saratoga Intl., Inc.'s devices?
Among its 2 most recently registered devices, Saratoga Intl., Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Saratoga Intl., Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Saratoga Intl., Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Saratoga Intl., Inc. in the registry?
The most recently registered devices listed for Saratoga Intl., Inc. include EMS and TRANSCUTANEOUS ELECTRICAL NERVE STIMULATION.