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FDA 510(k)

PORTABLE THERAPEUTIX SQUID ACTIVE COLD COMPRESSION DEVICE AND COLD PACK

K-Number: K123829 · 2013-04-03

ApplicantPortable Therapeutix, LLC
Decision Date2013-04-03
Product CodeIRP
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

PORTABLE THERAPEUTIX SQUID ACTIVE COLD COMPRESSION DEVICE AND COLD PACK is the device name listed in this FDA 510(k) record. The listed applicant is Portable Therapeutix, LLC. It received FDA 510(k) clearance on 2013-04-03 under 510(k) number K123829. The device is classified under product code IRP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PORTABLE THERAPEUTIX SQUID ACTIVE COLD COMPRESSION DEVICE AND COLD PACK?

PORTABLE THERAPEUTIX SQUID ACTIVE COLD COMPRESSION DEVICE AND COLD PACK is a medical device that received FDA 510(k) clearance on 2013-04-03. The listed applicant is Portable Therapeutix, LLC. The 510(k) number is K123829.

When did PORTABLE THERAPEUTIX SQUID ACTIVE COLD COMPRESSION DEVICE AND COLD PACK receive FDA 510(k) clearance?

PORTABLE THERAPEUTIX SQUID ACTIVE COLD COMPRESSION DEVICE AND COLD PACK received FDA 510(k) clearance on 2013-04-03, under 510(k) number K123829.

Who is the listed applicant for PORTABLE THERAPEUTIX SQUID ACTIVE COLD COMPRESSION DEVICE AND COLD PACK?

The FDA 510(k) record lists Portable Therapeutix, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PORTABLE THERAPEUTIX SQUID ACTIVE COLD COMPRESSION DEVICE AND COLD PACK?

The FDA product code for PORTABLE THERAPEUTIX SQUID ACTIVE COLD COMPRESSION DEVICE AND COLD PACK is IRP.

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Related Devices (Code: IRP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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