K-number	K162689
Device name	Vibrance Pelvic Trainer
Applicant	Bioinfinity (M) Sdn. Bhd.
Product code	HIR
Device class	Class II
Decision date	Jun 8, 2017
Decision	Substantially Equivalent
Regulation	884.1425

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Source

View the full FDA submission: accessdata.fda.gov

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Vibrance Pelvic Trainer

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