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510(k) Data Aggregation
K Number
K203661Device Name
CRYO Arctic, CRYO Penguin
Manufacturer
CryoScience North America, Inc.
Date Cleared
2022-05-25
(526 days)
Product Code
MLY
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
CryoScience North America, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CRYO Penguin is indicated for use when cold therapy is indicated for the temporary reduction of pain, swelling, inflammation, and hematoma from minor surgical procedures, minor sports injuries and as an adjunct to rehabilitative treatment (e.g., intermittent cold with stretch).
Device Description
The CRYO Penguin utilizes liquid nitrogen (LN2) to provide supercooled air for localized treatment. There are three main components to the device: Liquid nitrogen vessel with an evaporator, Cryogenic hose with a treatment handle, Electrical box and HMI panel with control software. The CRYO Penguin directs cold gas to the treatment area via a cryogenic hose tipped with a treatment handle. The handle is equipped with a red laser and LED lights to accurately position the treatment handle to provide a readout of the patient's skin temperature. The treatment handle does not physically touch the patient. To assure that the wand maintains the proper distance to the patient (approximately 15cm), there are two small lasers which provide two laser dots. When these dots converge to one dot, the handle is properly distanced. If the handle moves closer to the patient or further away, the dots no longer converge, providing a visual cue to the operator that the handle position has changed and is no longer optimal. Additionally, a temperature sensor and LED lights monitor optimal skin surface temperature; LED lights indicate skin temperature status as follows: GREEN the skin temperature is too high for optimum treatment (above 4°C) and should be further cooled. BLUE - the skin temperature is at the desired temperature (in the range of 2-4℃). RED the skin temperature is too low (below 2°C), and the treatment handle is removed or moved further away from the patient. If the temperature of the skin surface is below -1ºC for 1 second, auto-off function activates. The CRYO Penquin is software driven via pre-programmed protocol. Treatment time is monitored via countdown timer which is adjustable based on the treatment desired. Note: The protocol is selected prior to the session and may not be changed during the session. The CRYO Penquin may only be operated by a trained and authorized person.
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