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510(k) K031900

HANDMASTER by Ness-Neuromuscular Electrical Stimulation Systems — Product Code GZI

K031900 is an FDA 510(k) premarket notification submitted by Ness-Neuromuscular Electrical Stimulation Systems for the device "HANDMASTER". The FDA issued a decision of Substantially Equivalent on August 8, 2003. 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
August 8, 2003
Date Received
June 19, 2003
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)
  • K080219 — MODIFICATION TO:NESS L300 (February 28, 2008)
  • K053468 — NESS L300 (July 7, 2006)
  • 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