NESS H200 WIRELESS HAND REHABILITATION SYSTEM USER KIT AND CLINICAN KIT— 510(k) K111767

Name: FDA 510(k) clearance K111767
Creator: U.S. Food and Drug Administration
Published: 2011-09-15

Substantially Equivalent

Ness-Neuromuscular Electrical Stimulation Systems

FDA 510(k) clearance K111767 for NESS H200 WIRELESS HAND REHABILITATION SYSTEM USER KIT AND CLINICAN KIT, Substantially Equivalent on 2011-09-15. 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: 2011-06-23
Decision date: 2011-09-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ra'Anana, IL

Download summary PDF View on FDA.gov ↗

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