Data / Medical devices / Canada / Prime Pacific Health Innovations Corporation
Prime Pacific Health Innovations Corporation: FDA-registered device maker in PORT COQUITLAM British Columbia, Canada, 1 510(k) clearance
Prime Pacific Health Innovations Corporation is registered with the FDA (registration 9615415) in PORT COQUITLAM British Columbia, Canada. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated September 10, 2001. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 9615415
- FEI number
- 3006329956
- Address
- 1132 - 585 Seaborne Avenue, PORT COQUITLAM British Columbia, Canada, V3B 0M3
- Owner or operator
- PRIME PACIFIC HEALTH INNOVATIONS CORPORATION (9035957)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- November 28, 2007
- Registered through
- 2026
- Brand names listed
- AquaWing, Aquanet APS-100, Aquanet EC-2000, Aquanet GRY-500, FlexTube, Speculum and Kits, Disposable
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Chair And Table, Medical | KMN | 1 | Manufacturer | accessdata.fda.gov |
| Colonic Irrigation System | KPL | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Connector, Catheter | GCD | 1 | Manufacturer | accessdata.fda.gov |
| Speculum, Rectal | FFQ | 1 | Manufacturer, Repackager or relabeler | 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 10, 2001 | K000031 | AQUANET, MODEL EC 2000 | KPL | Substantially Equivalent | Prime Pacific Health Innovations Corporation | accessdata.fda.gov |
Compare with other makers
- All makers of Colonic Irrigation System
- All makers of Speculum, Rectal
- All makers of Connector, Catheter
- All makers of Chair And Table, Medical
Updated September 10, 2001. 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.