PORTABLE THERAPEUTIX SQUID ACTIVE COLD COMPRESSION DEVICE AND COLD PACK FOR OTC USE— 510(k) K133483

Name: FDA 510(k) clearance K133483
Creator: U.S. Food and Drug Administration
Published: 2014-03-11

Substantially Equivalent

Portable Therapeutix

FDA 510(k) clearance K133483 for PORTABLE THERAPEUTIX SQUID ACTIVE COLD COMPRESSION DEVICE AND COLD PACK FOR OTC USE, Substantially Equivalent on 2014-03-11. Applicant: Portable Therapeutix. Device class: 2.

Clearance details

Applicant: Portable Therapeutix
Product code: Code IRP
Device class: Class 2
Regulation: 21 CFR 890.5650
Advisory panel: Physical Medicine
Date received: 2013-11-13
Decision date: 2014-03-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ashland, MA, US

Download summary PDF View on FDA.gov ↗

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