Leo Unlimited, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Leo Unlimited, Inc. makes
Leo Unlimited, Inc. manufactures electrotherapy devices, including the EPITRON SUPER for transcutaneous electrical nerve stimulation (TENS), the COSMODYN-S for interferential muscle stimulation, and the EPILOT 80 S TM, a high-voltage pulsed galvanic stimulator.
These devices are classified under FDA Class I and Class II regulations, with some models authorised via the 510(k) pathway. The company’s products are listed in the FDA’s 510(k) registry, and the manufacturer is based in the United States.
Catalogue
Epitron Super Ref K834572
Regimes: 510(k) Registry: 510(k)Cosmodyn-S Interferential Muscle Stim Ref K833945
Regimes: 510(k) Registry: 510(k)Epilot 80 S Tm Ref K833946
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Leo Unlimited, Inc. have in the registry?
The registry currently lists 3 devices for Leo Unlimited, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Leo Unlimited, Inc.'s devices?
Among its 3 most recently registered devices, Leo Unlimited, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Leo Unlimited, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Leo Unlimited, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Leo Unlimited, Inc. in the registry?
The most recently registered devices listed for Leo Unlimited, Inc. include EPITRON SUPER, COSMODYN-S INTERFERENTIAL MUSCLE STIM and EPILOT 80 S TM.