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510(k) K080219

MODIFICATION TO:NESS L300 by Ness-Neuromuscular Electrical Stimulation Systems — Product Code GZI

K080219 is an FDA 510(k) premarket notification submitted by Ness-Neuromuscular Electrical Stimulation Systems for the device "MODIFICATION TO:NESS L300". The FDA issued a decision of Substantially Equivalent on February 28, 2008. The device falls under product code GZI (Stimulator, Neuromuscular, External Functional), a Class II device regulated under 21 CFR 882.5810. Ness-Neuromuscular Electrical Stimulation Systems has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 28, 2008
Date Received
January 29, 2008
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

Other clearances by Ness-Neuromuscular Electrical Stimulation Systems

  • K111767 — NESS H200 WIRELESS HAND REHABILITATION SYSTEM USER KIT AND CLINICAN KIT (September 15, 2011)
  • K053468 — NESS L300 (July 7, 2006)
  • K031900 — HANDMASTER (August 8, 2003)
  • K024279 — NESS CHILDREN SYSTEM (February 5, 2003)
  • K022776 — NESS SYSTEM (September 11, 2002)
  • K012823 — MODIFICATION TO HANDMASTER (November 14, 2001)

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)

FDA data resources