Cleared Traditional

K153163 - ReGrasp

K153163 is an FDA 510(k) clearance for ReGrasp, manufactured by Rehabtronics, Inc.. The device is a Class 2 Neurology device with product code GZI cleared through the Traditional 510(k) pathway after a 157-day FDA review.

K153163 · Rehabtronics, Inc. · Neurology device
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Apr 2016
Decision
157d
Days
Class 2
Risk

K153163 is an FDA 510(k) clearance for the ReGrasp. Classified as Stimulator, Neuromuscular, External Functional (product code GZI), Class II - Special Controls.

Submitted by Rehabtronics, Inc. (Edmonton, CA). The FDA issued a Cleared decision on April 7, 2016 after a review of 157 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 Rehabtronics, Inc. devices

FDA 510(k) Submission Details - K153163

510(k) Number K153163 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 2015
Decision Date April 07, 2016
Days to Decision 157 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
9d slower than avg
Panel avg: 148d · This submission: 157d
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 20
Devices cleared under the same product code (GZI) and FDA review panel - the closest regulatory comparables to K153163.
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