Data / Medical devices / United States / Specialty Health Products, LLC.
Specialty Health Products, LLC.: FDA-registered device maker in Phoenix, AZ, United States, 2 510(k) clearances
Specialty Health Products, LLC. is registered with the FDA (registration 2027347) in Phoenix, AZ, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated September 11, 2015. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2027347
- Address
- 2514 E Mohawk Ln Ste 111, Phoenix, AZ, United States, 85050
- Owner or operator
- SPECIALTY HEALTH PRODUCTS, CO LLC (2027347)
- Roles
- Manufacturer, Specification developer
- First device listed
- August 22, 2005
- Registered through
- 2026
- Brand names listed
- AQUA CLEANSE COLONIC DEVICE, Aqua Cleanse Enema Speculum Kits, Hydro-San Plus, Hydro-Sans Plus Enema Speculum Kits, Speculum and Kits, Disposable
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Colonic Irrigation System | KPL | 2 | Manufacturer | accessdata.fda.gov |
| Speculum, Rectal | FFQ | 1 | Specification developer | 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 |
|---|---|---|---|---|---|---|
| September 11, 2015 | K150381 | AQUA CLEANSE | KPL | Substantially Equivalent | Quality Medical Supply, Inc. | accessdata.fda.gov |
| August 3, 1989 | K891585 | HYDRO-SAN COLONIC IRRIGATION SYSTEM | KPL | Substantially Equivalent | Specialty Health Products, Inc. | accessdata.fda.gov |
Compare with other makers
Updated September 11, 2015. 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.