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510(k) Data Aggregation
K Number
K142385Device Name
Whisper Pump System
Manufacturer
Date Cleared
2015-05-22
(268 days)
Product Code
Regulation Number
878.4780Why did this record match?
Applicant Name (Manufacturer) :
Wound RX Medical, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Whisper Pump System™ is a suction device intended for aspiration of secretions and body fluids from wounds and is indicated for patients who would benefit from a suction device particularly as the device may promote wound healing. Whisper Pump System™ is appropriate for use on the following wounds:
- Pressure ulcers
- Diabetic/neuropathic ulcers
- Venous insufficiency ulcers
- Traumatic wounds
- Post-operative and dehisced surgical wounds
- Explored fistulas
- Skin flaps and grafts
Device Description
The Whisper Pump System™ is a device to remove bodily fluids for wound drainage and can be used by patients over an extended period of time as recommended by a physician. The device has a rechargeable battery and therefore is portable. A microprocessor controlled electronic battery charging unit in the suction device guarantees the safe charging of the battery, and overcharging of the battery. The Whisper Pump System™ itself is not a sterile device but can use disposable (sterile) items from other manufacturers but these items are not a part of the Whisper Pump System™, (e.g. various hose sets, containers, trocars and catheters) which have been designed for the wound drainage. The purpose of this traditional 510(k) was to modify the outer case dimensions, carrying handle ergonomics, canister bracket, and internal component reconfiguration.
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