Gentle Colonics, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Gentle Colonics, Inc. makes
Gentle Colonics, Inc. manufactures irrigation systems designed for colonic therapy, including the Gentle Colonics Irrigation System and the GC Irrigator. These devices are intended for use in medical or clinical settings to perform colonic irrigation procedures.
The company’s products are classified as Class II medical devices under FDA regulations and are listed via the 510(k) clearance process. The manufacturer is based in the United States.
Catalogue
Gentle Colonics Irrigation System Ref K002102
Regimes: 510(k) Registry: 510(k)Gc Irrigator Ref K980868
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Gentle Colonics, Inc. have in the registry?
The registry currently lists 2 devices for Gentle Colonics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Gentle Colonics, Inc.'s devices?
Among its 2 most recently registered devices, Gentle Colonics, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Gentle Colonics, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Gentle Colonics, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Gentle Colonics, Inc. in the registry?
The most recently registered devices listed for Gentle Colonics, Inc. include GENTLE COLONICS IRRIGATION SYSTEM and GC IRRIGATOR.