Data / Medical devices / United States / Clearwater Colon Hydrotherapy, Inc.
Clearwater Colon Hydrotherapy, Inc.: FDA-registered device maker in Ocala, FL, United States, 2 510(k) clearances
Clearwater Colon Hydrotherapy, Inc. is registered with the FDA (registration 1062839) in Ocala, FL, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated August 8, 2000. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1062839
- FEI number
- 3000718678
- Address
- 3145 SW 74th Ter, Ocala, FL, United States, 34474
- Owner or operator
- CLEARWATER COLON HYDROTHERAPY, INC. (9016062)
- Roles
- Manufacturer
- First device listed
- July 19, 2001
- Registered through
- 2026
- Brand names listed
- Colonic Irrigator, DISPOSABLE SPECULUM SPO1 LARGE, SPO2 SMALL
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Colonic Irrigation System | KPL | 2 | Manufacturer | accessdata.fda.gov |
| Speculum, Rectal | FFQ | 1 | 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 8, 2000 | K000388 | CLEARWATER COLON HYDROTHERAPY (DISPOSABLE SPECULUM SPO1 LARGE & SP02 SMALL) | KPL | Substantially Equivalent | Clearwater Colon Hydrotherapy, Inc. | accessdata.fda.gov |
| June 26, 1996 | K942867 | CLEARWATER COLON HYDROTHERAPY MODEL PPC-101 | KPL | Substantially Equivalent | Clearwater Colon Hydrotherapy, Inc. | accessdata.fda.gov |
Compare with other makers
Updated August 8, 2000. 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.