Name: Predicase
Price: 199 USD

K-number	K123636
Device name	H200 WIRELESS HAND REHABILITATION SYSTEM WITH OPTIONAL INTELLI-CONNECT EARPIECE TRIGGERING DEVICE
Applicant	Bioness, Inc.
Product code	GZI
Device class	Class II
Decision date	May 1, 2013
Decision	Substantially Equivalent
Regulation	882.5810

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Source

View the full FDA submission: accessdata.fda.gov

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H200 WIRELESS HAND REHABILITATION SYSTEM WITH OPTIONAL INTELLI-CONNECT EARPIECE TRIGGERING DEVICE

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