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510(k) Data Aggregation
K Number
K121001Device Name
COPRESSION SYSTEMS (MODELS CMP-001 AND CMP-002)
Manufacturer
Date Cleared
2012-04-17
(15 days)
Regulation Number
870.5800Why did this record match?
Applicant Name (Manufacturer) :
NOVITAS MEDICAL, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Compression System is intended to function as an intermittent, sequential pneumatic compression device and each model provides the following specific therapeutic functions:
The CMP-001 (Compression Plus) is intended for:
- Treatment of disorders associated with vascular or lymphatic insufficiency such as . Chronic Venous Insufficiency (CVI), venous stasis ulcers, post-mastectomy edema, chronic lymphedema.
- Reduction of edema associated with soft tissue injuries such as burns, postoperative . edema, and ligament sprains.
- Optional localized thermal therapy (hot or cold) for post traumatic and post surgical . medical and/or surgical conditions
- Aids the blood flow back to the heart .
- Treats and assists healing of cutaneous ulceration (wounds), reduce would healing ● time enhance arterial circulation (blood flow), reduce compartmental pressures, reduce edema (swelling), reduce the need for anticoagulant (blood thinning) medications
The CMP-002 (DVTmax) is intended for:
- Treatment of disorders associated with vascular or lymphatic insufficiency such as ● Chronic Venous Insufficiency (CVI), venous stasis ulcers, post-mastectomy edema chronic lymphedema
- Reduction of edema associated with soft tissue injuries such as burns, postoperative . edema, and ligament sprains
- Optional localized thermal therapy (hot or cold) for post traumatic and post surgical ● medical and/or surgical conditions
- Decrease the risk of deep venous thrombosis (DVT) .
- Aids the blood flow back to the heart, .
- Treats and assists healing of cutaneous ulceration (wounds), reduce would healing ● time, enhance arterial circulation (blood flow), reduce compartmental pressures, reduce edema (swelling), reduce the need for anticoagulant (blood thinning) medications
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