Cleared Traditional

K111767 - NESS H200 WIRELESS HAND REHABILITATION SYSTEM USER KIT AND CLINICAN KIT

K111767 is an FDA 510(k) clearance for NESS H200 WIRELESS HAND REHABILITATION ..., manufactured by Ness-Neuromuscular Electrical Stimulation Systems. The device is a Class 2 Neurology device with product code GZI cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K111767 · Ness-Neuromuscular Electrical Stimulation Systems · Neurology device
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Sep 2011
Decision
84d
Days
Class 2
Risk

K111767 is an FDA 510(k) clearance for the NESS H200 WIRELESS HAND REHABILITATION SYSTEM USER KIT AND CLINICAN KIT. Classified as Stimulator, Neuromuscular, External Functional (product code GZI), Class II - Special Controls.

Submitted by Ness-Neuromuscular Electrical Stimulation Systems (Ra'Anana, IL). The FDA issued a Cleared decision on September 15, 2011 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5810 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K111767

510(k) Number K111767 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 2011
Decision Date September 15, 2011
Days to Decision 84 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 149d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GZI Device Classification - Class 2, Special Controls

Product Code GZI Stimulator, Neuromuscular, External Functional
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5810
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - GZI Stimulator, Neuromuscular, External Functional

All 56
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K111767 · NESS H200 WIRELESS HAND REHABILITATION SYSTEM USER KIT AND CLINICAN KIT
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