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510(k) Data Aggregation
K Number
K220761Device Name
CIRCUL8 Connect DVT Prevention Device
Manufacturer
Date Cleared
2022-06-03
(80 days)
Product Code
Regulation Number
870.5800Why did this record match?
Applicant Name (Manufacturer) :
Ortho8, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
CIRCUL8 Connect DVT Prevention Device is intended to be an easy-to-use portable system, prescribed by a physician, for use in the home or clinical setting to help prevent the onset of DVT in patients by stimulating blood flow in the extremities (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 dernatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency and reduction of edema in the lower limbs.
The unit can also be used as an aid in the prophylaxis for DVT by persons expecting to be stationary for long periods of time.
Device Description
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