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510(k) Data Aggregation
K Number
K193079Device Name
ICE COMPRESSION FIRST, DUO, & MOOVE Systems
Manufacturer
Date Cleared
2021-01-11
(433 days)
Regulation Number
890.5650Why did this record match?
Applicant Name (Manufacturer) :
mks paris
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The ICE COMPRESSION FIRST, DUO, and MOOVE Systems combine cold and compression therapies. They are intended to treat post-surgical and acute injuries to reduce edema, swelling, and pain where cold and compression are indicated. They are intended to be used by or on the order of licensed healthcare professionals in hospital, outpatient clinics, athletic training settings, or home settings.
Device Description
The ICE COMPRESSION FIRST, DUO, & MOOVE System and its accessories, including the Splints, is designed to treat post-surgical and acute injuries to reduce edema, swelling, and pain when cold and compression are indicated. The ICE COMPRESSION System provides cold and compression therapy using ice and water. The ICE COMPRESSION System is a DC-powered, software-controlled device that delivers compressed air and chilled water from the Control Module through tubing to a Splint that is designed for a specific body part (e.g., shoulder, wrist, knee, leg, hip and ankle, back) to treat pain and swelling from injuries and/or surgical interventions.
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