MODIFICATION TO HANDMASTER— 510(k) K012823

Name: FDA 510(k) clearance K012823
Creator: U.S. Food and Drug Administration
Published: 2001-11-14

Substantially Equivalent

Ness-Neuromuscular Electrical Stimulation Systems

FDA 510(k) clearance K012823 for MODIFICATION TO HANDMASTER, Substantially Equivalent on 2001-11-14. Applicant: Ness-Neuromuscular Electrical Stimulation Systems. Device class: 2.

Clearance details

Applicant: Ness-Neuromuscular Electrical Stimulation Systems
Product code: Code GZI
Device class: Class 2
Regulation: 21 CFR 882.5810
Advisory panel: Neurology
Date received: 2001-08-16
Decision date: 2001-11-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GZI

view all

K242704 — Synchrony (20-3000)2025-06-05
K243828 — CIONIC NEURAL SLEEVE (NS-200)2025-05-02
K240632 — Neuvotion NeuStim NN-012024-11-22
K233006 — MyndMove, MyndMove 2.02024-06-25
K230997 — EvoWalk 1.0 System2023-12-28

More clearances from Ness-Neuromuscular Electrical Stimulation Systems

view all

K111767 — NESS H200 WIRELESS HAND REHABILITATION SYSTEM USER KIT AND CLINICAN KIT2011-09-15
K080219 — MODIFICATION TO:NESS L3002008-02-28
K053468 — NESS L3002006-07-07
K031900 — HANDMASTER2003-08-08
K024279 — NESS CHILDREN SYSTEM2003-02-05

Data sourced from openFDA. This site is unofficial and independent of the FDA.