Home / 510(k) Clearances / K120853

510(k) K120853

NESS L300 SYSTEM KIT, LEFT, NESS L300 SYSTEM KIT, RIGHT, SMALL NESS L300 SYSTEM KIT, RIGHT, SMALL NESS L300 SYSTEM KIT, by Bioness, Inc. — Product Code GZI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 20, 2012
Date Received
March 21, 2012
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Neuromuscular, External Functional
Device Class
Class II
Regulation Number
882.5810
Review Panel
NE
Submission Type

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  • K123636 — H200 WIRELESS HAND REHABILITATION SYSTEM WITH OPTIONAL INTELLI-CONNECT EARPIECE (May 1, 2013)

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