Name: Predicase
Price: 199 USD

K-number	K133483
Device name	PORTABLE THERAPEUTIX SQUID ACTIVE COLD COMPRESSION DEVICE AND COLD PACK FOR OTC USE
Applicant	Portable Therapeutix
Product code	IRP
Device class	Class II
Decision date	Mar 11, 2014
Decision	Substantially Equivalent
Regulation	890.5650

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Source

View the full FDA submission: accessdata.fda.gov

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PORTABLE THERAPEUTIX SQUID ACTIVE COLD COMPRESSION DEVICE AND COLD PACK FOR OTC USE

Everything you need for a 510(k) submission. Nothing you don't.