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510(k) Data Aggregation
K Number
K141360Device Name
TRIPLEPLAY PRO
Manufacturer
Date Cleared
2014-06-12
(20 days)
Product Code
Regulation Number
870.5800Why did this record match?
Applicant Name (Manufacturer) :
WILDCAT MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
TriplePlay Pro (supplied with a pair of model TP-3333, TP-3636, or TP-3434 "cuffs") is indicated for being an easy to use portable system, prescribed by a physician, to help prevent the onset of DVT in patients by stimulating blood flow in the extremeties (simulating muscle contractions). This device can be used to:
- Aid in the prevention of DVT; .
- Enhance blood circulation; .
- Diminish post-operative pain and swelling; ●
- Reduce wound healing time; ●
- Aid in the treatment and healing of stasis dermatitis, venous stasis ulcers, arterial and . diabetic leg ulcers, chronic venous insufficiency and reduction of edema in the lower . limbs:
- As a prophylaxis for DVT by persons expecting to be stationary for long periods of time .
Device Description
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