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510(k) Data Aggregation
K Number
K052243Device Name
PROACT WITH GEL OR PROACT 1
Manufacturer
Date Cleared
2006-04-12
(238 days)
Product Code
Regulation Number
870.5800Why did this record match?
Applicant Name (Manufacturer) :
PROACT INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The ProAct with Gel is a prescriptive device indicated for:
- Lymphedema - primary and secondary
- Prevention of venous stasis
- Prevention of Deep Vein Thrombosis (DVT)
- Edema following trauma and sports injuries
- Post immobilization edema
Device Description
The ProAct 1 or ProAct with gel device is a gradient sequential compression device used in the treat ment of lymphedema. The ProAct with gel is a modification to the ProAct 1 device that received FDA marketing clearance under 510(k) K003909. The ProAct with gel uses the same powered control device that delivers gradient sequential compression pressure to the chambered compressible limb sleeves. The device is composed of three components:
- Lightweight, portable control unit .
- Compressible limb sleeves with gel in 3 sizes for arms and legs (Brookwood 70 denier MD Nylon . and DAF Breathable 270 Nylon)
- . Pneumatic connecting tubes
The subject device includes sleeves with Nosocryl D60 gel in the chambers. The gel was added to address market requests.
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