Home / 510(k) Clearances / K103343

510(k) K103343

L300 PLUS SYSTEM (RIGHT, LEFT), L300 PLUS SYSTEM UPGRADE KIT (RIGHT, LEFT) by Bioness, Inc. — Product Code GZI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 29, 2011
Date Received
November 15, 2010
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.

  • K211965 — StimRouter Neuromodulation System (February 23, 2022)
  • K200482 — StimRouter Neuromodulation System (March 27, 2020)
  • K200262 — L100 Go System (March 4, 2020)
  • K190047 — StimRouter Neuromodulation System (October 31, 2019)
  • K191587 — L360 Thigh System (September 12, 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)

Other clearances for product code GZI

  • K242704 — Synchrony (20-3000) (June 5, 2025)
  • K243828 — CIONIC NEURAL SLEEVE (NS-200) (May 2, 2025)
  • K240632 — Neuvotion NeuStim NN-01 (November 22, 2024)
  • 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)