Cleared Traditional

K123636 - H200 WIRELESS HAND REHABILITATION SYSTEM WITH OPTIONAL INTELLI-CONNECT EARPIECE TRIGGERING DEVICE

K123636 is an FDA 510(k) clearance for H200 WIRELESS HAND REHABILITATION SYSTE..., manufactured by Bioness, Inc.. The device is a Class 2 Neurology device with product code GZI cleared through the Traditional 510(k) pathway after a 159-day FDA review.

K123636 · Bioness, Inc. · Neurology device
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May 2013
Decision
159d
Days
Class 2
Risk

K123636 is an FDA 510(k) clearance for the H200 WIRELESS HAND REHABILITATION SYSTEM WITH OPTIONAL INTELLI-CONNECT EARPIE.... Classified as Stimulator, Neuromuscular, External Functional (product code GZI), Class II - Special Controls.

Submitted by Bioness, Inc. (Valencia, US). The FDA issued a Cleared decision on May 1, 2013 after a review of 159 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Bioness, Inc. devices

FDA 510(k) Submission Details - K123636

510(k) Number K123636 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 2012
Decision Date May 01, 2013
Days to Decision 159 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
10d slower than avg
Panel avg: 149d · This submission: 159d
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 55
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