Name: Predicase
Price: 199 USD

K-number	K123829
Device name	PORTABLE THERAPEUTIX SQUID ACTIVE COLD COMPRESSION DEVICE AND COLD PACK
Applicant	Portable Therapeutix, LLC
Product code	IRP
Device class	Class II
Decision date	Apr 3, 2013
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

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