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510(k) Data Aggregation
K Number
K162481Device Name
RF1400 Active Compression Wrap
Manufacturer
RECOVERY FORCE LLC
Date Cleared
2017-02-16
(163 days)
Product Code
JOW
Regulation Number
870.5800Why did this record match?
Applicant Name (Manufacturer) :
RECOVERY FORCE LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The RF1400 Active Compression Wrap is intended to be a portable system, prescribed by healthcare professionals, to treat the following conditions by stimulating blood flow in the legs:
· Aid in the prevention of DVT (deep vein thrombosis);
• Enhance blood circulation;
· Diminish post-operative pain and swelling;
- · Reduce wound healing time;
· Aid in the treatment and healing of: stasis dermatits, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency, chronic lymphedema, and reduction of edema in the lower limbs;
· As a prophylaxis for DVT by persons expecting to be stationary for long periods of time.
· Reduction of edema associated with soft tissue injuries, such as burns, postoperative or post-immobilization edema, or ligament sprains.
The device can be used in the home or clinical setting. The device is intended for use in an adult patient population.
Device Description
The RF1400 Active Compression Wrap is a lightweight, portable, rechargeable battery powered, prescriptive device that helps stimulate blood flow in the lower limb through the use of intermittent sequential compression. The wrap contains nickel titanium, martensite phase change wires, using a battery-powered microprocessor to "excite" and "relax" the wires resulting in compression. The battery and microprocessor components are protectively housed in a plastic controller case that is permanently attached to the wrap. A single, touch control button interface and a RGB LED light indicator provide the user interface, and there is a port for connecting the battery charger plug. The wrap is available in a wide range of sizes XS, S, M, and L, to accommodate varying anatomy sizes.
The wrap is divided into three discrete zones which are externally applied to the limb. After one zone is fully activated for a period of time and turns off, then the next zone is activated. This cycle continues until all three zones have activated and turned off. Then the sequence is repeated after a short delay. This cycle repeats until the unit is turned off. The wrap may be used on one or both legs. When used on both legs, the wraps operately. The wrap is supplied with a rechargeable battery, which can be charged when not in use.
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