NESS H200 WIRELESS HAND REHABILITATION SYSTEM USER KIT AND CLINICAN KIT

Stimulator, Neuromuscular, External Functional

NESS-NEUROMUSCULAR ELECTRICAL STIMULATION SYSTEMS

The following data is part of a premarket notification filed by Ness-neuromuscular Electrical Stimulation Systems with the FDA for Ness H200 Wireless Hand Rehabilitation System User Kit And Clinican Kit.

Pre-market Notification Details

• Device ID: K111767
• 510k Number: K111767
• Device Name: NESS H200 WIRELESS HAND REHABILITATION SYSTEM USER KIT AND CLINICAN KIT
• Classification: Stimulator, Neuromuscular, External Functional
• Applicant: NESS-NEUROMUSCULAR ELECTRICAL STIMULATION SYSTEMS 19 HA'HAROSHET ST. Ra'anana, IL 43654
• Contact: Monica Stachura,jd
• Correspondent: Monica Stachura,jd; NESS-NEUROMUSCULAR ELECTRICAL STIMULATION SYSTEMS 19 HA'HAROSHET ST. Ra'anana, IL 43654
• Product Code: GZI
• CFR Regulation Number: 882.5810 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-06-23
• Decision Date: 2011-09-15

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00815962020290	K111767	000