NESS H200 WIRELESS HAND REHABILITATION SYSTEM USER KIT AND CLINICAN KIT


Device Classification Name

stimulator, neuromuscular, external functional

510(k) Number K111767
Device Name NESS H200 WIRELESS HAND REHABILITATION SYSTEM USER KIT AND CLINICAN KIT
Applicant
NESS-NEUROMUSCULAR ELECTRICAL STIMULATION SYSTEMS
19 ha’haroshet st.
ra’anana, 

IL

43654

Applicant Contact monica stachura,jd
Correspondent
NESS-NEUROMUSCULAR ELECTRICAL STIMULATION SYSTEMS
19 ha’haroshet st.
ra’anana, 

IL

43654

Correspodent Contact monica stachura,jd
Regulation Number 882.5810
Classification Product Code
GZI  
Date Received 06/23/2011
Decision Date 09/15/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Ear Nose & Throat

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No