Name: Predicase
Price: 199 USD

K-number	K150078
Device name	PowerDot(R) PD-01 Muscle Stimulator (with PowerDot(R) Mobile Application)
Applicant	Smartmissimo Technologies Pte, Ltd.
Product code	NGX
Device class	Class II
Decision date	Sep 30, 2015
Decision	Substantially Equivalent
Regulation	890.5850

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Source

View the full FDA submission: accessdata.fda.gov

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PowerDot(R) PD-01 Muscle Stimulator (with PowerDot(R) Mobile Application)

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