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510(k) K191587

L360 Thigh System by Bioness, Inc. — Product Code GZI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 2019
Date Received
June 14, 2019
Clearance Type
Traditional
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

Other clearances by Bioness, Inc.

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  • K200262 — L100 Go System (March 4, 2020)
  • K190047 — StimRouter Neuromodulation System (October 31, 2019)
  • K190285 — L300 Go System (March 14, 2019)
  • K173682 — L300 Go System (March 9, 2018)
  • K162407 — L300 Go System (January 27, 2017)
  • K142432 — StimRouter Lead Kit/StimRouter Surgical Tool Kit/StimRouter Clinician Kit/StimRo (February 20, 2015)
  • K123636 — H200 WIRELESS HAND REHABILITATION SYSTEM WITH OPTIONAL INTELLI-CONNECT EARPIECE (May 1, 2013)
  • K122784 — NESS L300 SYSTEM KIT, LEF MODEL LG3-5100; NESS L300 SYSTEM KIT, RIGHT MODEL LG3- (December 27, 2012)

Other clearances for product code GZI

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  • K233006 — MyndMove, MyndMove 2.0 (June 25, 2024)
  • K230997 — EvoWalk 1.0 System (December 28, 2023)
  • K221823 — Cionic Neural Sleeve NS-100 (July 21, 2022)
  • K213925 — MyoCycle MC-2 (Home / Home + / Pro / Pro +) (April 25, 2022)
  • K212149 — MyndMove 2.0 (March 3, 2022)
  • K213622 — Cionic Neural Sleeve NS-100 (February 14, 2022)
  • K202110 — MStim Drop Model: LGT-233 (November 5, 2021)