Portable Therapeutix Squid Active Cold Compression Device and Cold Pack for Otc Use
Portable Therapeutix
FDA Clearance Information
The Portable Therapeutix Squid was cleared via the FDA 510(k) pathway on March 11, 2014. It is manufactured by Portable Therapeutix and classified as a Class 2 medical device.
What It Is
FDA-Cleared Indications
- Temporary relief of pain associated with musculoskeletal injuries.
- Temporary reduction of swelling associated with musculoskeletal injuries.
- Use with a cold pack and compression unit for over-the-counter management of pain and swelling.
Clinical Applications
- Managing pain after musculoskeletal injury, such as a sprain or strain.
- Reducing swelling during recovery from an acute musculoskeletal injury.
- Applying cold compression during postoperative orthopedic recovery when recommended by a clinician.
- Use in outpatient, rehabilitation, sports-medicine, or home settings according to the product instructions.
Practical Considerations
- The device is available in different sizes or wraps for coverage of different body regions; the selected size should fit securely without excessive compression.
- Use only the compatible cold pack, compression unit, and accessories specified by the manufacturer. Follow instructions for cold exposure time and skin checks.
- Do not apply over areas with impaired sensation or circulation, open wounds, untreated infection, or suspected vascular compromise unless specifically directed by a clinician.
- The FDA record provided does not establish MRI safety. Keep the device and compression unit outside the MRI environment unless the current manufacturer labeling confirms MR Safe or MR Conditional status.
- Cold therapy and compression may not be appropriate for some patients with severe peripheral arterial disease, cold sensitivity, impaired sensation, or conditions that increase bleeding or skin-injury risk.
Linked Studies (6)
Embolization of middle meningeal artery for chronic subdural hematoma: Do we have sufficient evidence?
Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences
View Source →Life History of the Arctic Squid Gonatus fabricii (Cephalopoda: Oegopsida) Reconstructed by Analysis of Individual Ontogenetic Stable Isotopic Trajectories.
Animals : an open access journal from MDPI
View Source →Oral administration of squid lecithin-transphosphatidylated phosphatidylserine improves memory impairment in aged rats.
Progress in neuro-psychopharmacology & biological psychiatry
View Source →Temperature dependence of bistability in squid giant axons with alkaline intracellular pH.
The Journal of membrane biology
RCT|prospective|retrospective|case Series|other View Source →Relationship between presynaptic calcium current and postsynaptic potential in squid giant synapse.
Biophysical journal
Other View Source →Electrical properties of the squid axon sheath.
Biophysical journal
RCT|prospective|retrospective|case Series|other View Source →Frequently Asked Questions
What is the Portable Therapeutix Squid used for?
It is used for reducing pain and swelling in musculoskeletal injuries through cold compression therapy.
What specialties typically use this device?
Orthopedic surgeons, sports medicine specialists, and physical therapists commonly use this device.
What are the FDA-cleared indications?
The device is indicated for managing pain and swelling in conditions like post-surgical recovery and acute sports injuries.