PRO FIT DISPOSABLE RECTAL SPECULUM, MODELS 8116 AND 8117
PRIME PACIFIC HEALTH INNOVATIONS CORPORATION
PRIME PACIFIC HEALTH INNOVATIONS CORPORATION
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 9615415 | 3006329956 | PRIME PACIFIC HEALTH INNOVATIONS CORPORATION | 1 | N | 2026-01-01 | 1132 - 585 Seaborne Avenue PORT COQUITLAM British Columbia CA V3B 0M3 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 18162 | 1731073827 | K000031 | AQUANET, MODEL EC 2000 | KPL | 2001-09-10 |
| 18162 | 1323662694 | ||||
| 18162 | 1698027845 | ||||
| 18162 | 1964778329 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| KPL | 1 | 2001-09-10 |
PMN#
AQUANET, MODEL EC 2000
PRIME PACIFIC HEALTH INNOVATIONS CORPORATION
GUDID#
Pro-Fit - The Pro-Fit Regular Kit is a Colon Hydrotherapy Disposable Single-Use Speculum Kit consisting of a regular size speculum with insertion stop disc, a water inflow tube and a waste hose.
2016-09-23
Pro-Fit - The Pro-Fit Small Kit is a Colon Hydrotherapy Disposable Single-Use Speculum Kit consisting of a small size speculum with insertion stop disc, a water inflow tube and a waste hose.
2016-09-23
Pro-Fit - The Pro-Fit Regular Kit is a Colon Hydrotherapy Disposable Single-Use Speculum Kit consisting of a regular size speculum with insertion guide rings, a water inflow tube and a waste hose.
2016-09-23
Pro-Fit - The Pro-Fit Small Kit is a Colon Hydrotherapy Disposable Single-Use Speculum Kit consisting of a small size speculum with insertion guide rings, a water inflow tube and a waste hose.
2016-09-23
Pro-Fit Eco-Flex - The Pro-Fit Eco-Flex Regular Kit is a Colon Hydrotherapy Disposable Single-Use Speculum Kit consisting of a regular size speculum with insertion stop disc, a water inflow tube and a collapsible waste hose.
2016-09-23
Pro-Fit Eco-Flex - The Pro-Fit Eco-Flex Small Kit is a Colon Hydrotherapy Disposable Single-Use Speculum Kit consisting of a small size speculum with insertion stop disc, a water inflow tube and a collapsible waste hose.
2016-09-23
Pro-Fit Eco-Flex - The Pro-Fit Eco-Flex Regular Kit is a Colon Hydrotherapy Disposable Single-Use Speculum Kit consisting of a regular size speculum with insertion guide rings, a water inflow tube and a collapsible waste hose.
2016-09-23
Pro-Fit Eco-Flex - The Pro-Fit Eco-Flex Small Kit is a Colon Hydrotherapy Disposable Single-Use Speculum Kit consisting of a small size speculum with insertion guide rings, a water inflow tube and a collapsible waste hose.
2016-09-23
Pro-Fit - The Pro-Fit Universal Kit is a Colon Hydrotherapy Disposable Single-Use Speculum Kit consisting of a universal size speculum (one piece), a water inflow tube and a waste hose.
2016-09-23
Pro-Fit Eco-Flex - The Pro-Fit Eco-Flex Universal Kit is a Colon Hydrotherapy Disposable Single-Use Speculum Kit consisting of a universal size speculum (one piece), a water inflow tube and a collapsible waste hose.
2016-09-23
Pro-Fit - The Pro-Fit Small Speculum Pack is a package containing 10 individual Disposable, Single-use Speculums with insertion stop disc to be used with compatible Colon Hydrotherapy Devices.
2016-09-30
Pro-Fit - The Pro-Fit Small Speculum Pack is a package containing 20 individual Disposable, Single-use Speculums with insertion stop disc to be used with compatible Colon Hydrotherapy Devices.
2016-09-30
Pro-Fit - The Pro-Fit Regular Speculum Pack is a package containing 10 individual Disposable, Single-use Speculums with insertion stop disc to be used with compatible Colon Hydrotherapy Devices.
2016-09-30
Pro-Fit - The Pro-Fit Regular Speculum Pack is a package containing 20 individual Disposable, Single-use Speculums with insertion stop disc to be used with compatible Colon Hydrotherapy Devices.
2016-09-30
Pro-Fit - The Pro-Fit Small Speculum Pack is a package containing 10 individual Disposable, Single-use Speculums with insertion guide rings to be used with compatible Colon Hydrotherapy Devices.
2016-09-30
Pro-Fit - The Pro-Fit Small Speculum Pack is a package containing 20 individual Disposable, Single-use Speculums with insertion guide rings to be used with compatible Colon Hydrotherapy Devices.
2016-09-30
Pro-Fit - The Pro-Fit Regular Speculum Pack is a package containing 10 individual Disposable, Single-use Speculums with insertion guide rings to be used with compatible Colon Hydrotherapy Devices.
2016-09-30
Pro-Fit - The Pro-Fit Regular Speculum Pack is a package containing 20 individual Disposable, Single-use Speculums with insertion guide rings to be used with compatible Colon Hydrotherapy Devices.
2016-09-30
Pro-Fit - The Pro-Fit Universal Speculum Pack is a package containing 10 individual Disposable, Single-use Speculums to be used with compatible Colon Hydrotherapy Devices.
2016-09-30
Pro-Fit - The Pro-Fit Universal Speculum Pack is a package containing 20 individual Disposable, Single-use Speculums to be used with compatible Colon Hydrotherapy Devices.
2016-09-30
Aquanet - The Aquanet APS-100 is a colon hydrotherapy device. It introduces water at a comfortable temperature into the large intestine. It is a system for filling and emptying water into and out of the colon and thus cleansing the colon of its contents when medically indicated such as before radiological or endoscopic examination.
2016-09-23
Aquanet - The Aquanet EC-2000 is a colon hydrotherapy device. It introduces water at a comfortable temperature into the large intestine. It is a system for filling and emptying water into and out of the colon and thus cleansing the colon of its contents when medically indicated such as before radiological or endoscopic examination.
2016-09-23
Aquanet - The Aquanet GRY-500 is a colon hydrotherapy device. It introduces water at a comfortable temperature into the large intestine. It is a system for filling and emptying water into and out of the colon and thus cleansing the colon of its contents when medically indicated such as before radiological or endoscopic examination.
2016-09-23
FlexTube - The FlexTube is a connector intended to be used with the AquaWing Treatment Table. It fits the flow-through fitting of the table and allows water to pass through the portion of the table that supports the patients legs during treatment.
2023-10-27
AquaWing - The AquaWing is a treatment table intended to be used as a support for patients who are undergoing colon hydrotherapy.
2023-10-27
FlexTube - The FlexTube is a connector intended to be used with the AquaWing Treatment Table. It fits the flow-through fitting of the table and allows water to pass through the portion of the table that supports the patients legs during treatment.
2023-10-27
FlexTube - The FlexTube is a connector intended to be used with the AquaWing Treatment Table. It fits the flow-through fitting of the table and allows water to pass through the portion of the table that supports the patients legs during treatment.
2023-10-27
Pro-Fit - The Pro-Fit Regular Kit is a Colon Hydrotherapy Disposable Single-Use Speculum Kit consisting of a regular size speculum with insertion stop disc, a w
2016-09-23
Pro-Fit - The Pro-Fit Small Kit is a Colon Hydrotherapy Disposable Single-Use Speculum Kit consisting of a small size speculum with insertion stop disc, a water
2016-09-23
Pro-Fit - The Pro-Fit Regular Kit is a Colon Hydrotherapy Disposable Single-Use Speculum Kit consisting of a regular size speculum with insertion guide rings, a
2016-09-23
Pro-Fit - The Pro-Fit Small Kit is a Colon Hydrotherapy Disposable Single-Use Speculum Kit consisting of a small size speculum with insertion guide rings, a wat
2016-09-23
Pro-Fit Eco-Flex - The Pro-Fit Eco-Flex Regular Kit is a Colon Hydrotherapy Disposable Single-Use Speculum Kit consisting of a regular size speculum with insertion stop
2016-09-23
Pro-Fit Eco-Flex - The Pro-Fit Eco-Flex Small Kit is a Colon Hydrotherapy Disposable Single-Use Speculum Kit consisting of a small size speculum with insertion stop disc
2016-09-23
Pro-Fit Eco-Flex - The Pro-Fit Eco-Flex Regular Kit is a Colon Hydrotherapy Disposable Single-Use Speculum Kit consisting of a regular size speculum with insertion guide
2016-09-23
Pro-Fit Eco-Flex - The Pro-Fit Eco-Flex Small Kit is a Colon Hydrotherapy Disposable Single-Use Speculum Kit consisting of a small size speculum with insertion guide rin
2016-09-23
Pro-Fit - The Pro-Fit Universal Kit is a Colon Hydrotherapy Disposable Single-Use Speculum Kit consisting of a universal size speculum (one piece), a water infl
2016-09-23
Pro-Fit Eco-Flex - The Pro-Fit Eco-Flex Universal Kit is a Colon Hydrotherapy Disposable Single-Use Speculum Kit consisting of a universal size speculum (one piece), a w
2016-09-23