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510(k) Data Aggregation
K Number
K133483Device Name
PORTABLE THERAPEUTIX SQUID ACTIVE COLD COMPRESSION DEVICE AND COLD PACK FOR OTC USE
Manufacturer
PORTABLE THERAPEUTIX
Date Cleared
2014-03-11
(118 days)
Product Code
IRP, IME
Regulation Number
890.5650Why did this record match?
Applicant Name (Manufacturer) :
PORTABLE THERAPEUTIX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Squid Active Cold Compression device and Cold Pack for the temporary relief of minor muscle aches and pains.
The compression device is indicated for temporary increase in circulation of the treated areas in people who are in good health, and simulates kneeding and stroking of tissues using an inflatable garment.
The cold pack is indicated for localized therapy in situations where cold temperature therapy is necessary or desirable.
Device Description
The Squid Active Cold Compression device and Cold Pack for OTC Use combines intermittent compression with cold therapy. The Squid simulates kneading and stroking of tissues using an inflatable garment attached to a gel ice pack and connected to a preprogrammed air pump. The Squid may be used for the leg, foot, feet, arm, shoulders, lower back, and hands.
The device is manufactured with the following components:
- 1. A portable external pump-controller unit containing the pneumatic compressor (air pump) that may be run on AC-DC external power supply or a built-in lithium battery.
- 2. A wrap that contains an air bladder with sequential compression capability and Velcro attachments for the cold pack. The wrap connects to the pump controller via a flexible tube. There may also be an accessory piece to the wrap to provide an additional securing mechanism. Wraps come in two configurations and three sizes.
- 3. Reusable thermogel cold pack
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K Number
K123829Device Name
PORTABLE THERAPEUTIX SQUID ACTIVE COLD COMPRESSION DEVICE AND COLD PACK
Manufacturer
PORTABLE THERAPEUTIX, LLC
Date Cleared
2013-04-03
(112 days)
Product Code
IRP, IME
Regulation Number
890.5650Why did this record match?
Applicant Name (Manufacturer) :
PORTABLE THERAPEUTIX, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Squid Active Cold Compression device and Cold Pack is indicated for the temporary relief of minor muscle aches and pains.
The compression device is indicated for temporary increase in circulation of the treated areas in people who are in good health, and simulates kneeding and stroking of tissues using an inflatable garment.
The cold pack is indicated for localized therapy in situations where a physician determines that cold temperature therapy is necessary or desirable.
Device Description
The Squid Active Cold Compression device and Cold Pack combines intermittent compression with cold therapy. The Squid simulates kneading and stroking of tissues using an inflatable garment attached to a gel ice pack and connected to a pre-programmed air pump. The Squid may be used for the leg, foot, feet, arm, shoulders, lower back, and hands.
The device is manufactured with the following components:
1. A portable external pump-controller unit containing the pneumatic compressor (air pump) that may be run on AC-DC external power supply or a built-in lithium battery.
2. A wrap that contains an air bladder with sequential compression capability and Velcro attachments for the cold pack. The wrap connects to the pump controller via a flexible tube. There may also be an accessory piece to the wrap to provide an additional securing mechanism. Wraps come in two configurations and three sizes.
3. Reusable thermogel cold pack
Ask a Question
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