Cleared Traditional

K221772 - NeuroRPM

K221772 is an FDA 510(k) clearance for NeuroRPM, manufactured by New Touch Digital, Inc.. The device is a Class 2 Neurology device with product code GYD cleared through the Traditional 510(k) pathway after a 269-day FDA review.

K221772 · New Touch Digital, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2023
Decision
269d
Days
Class 2
Risk

K221772 is an FDA 510(k) clearance for the NeuroRPM. Classified as Transducer, Tremor (product code GYD), Class II - Special Controls.

Submitted by New Touch Digital, Inc. (Washington, US). The FDA issued a Cleared decision on March 17, 2023 after a review of 269 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1950 - 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 New Touch Digital, Inc. devices

FDA 510(k) Submission Details - K221772

510(k) Number K221772 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 2022
Decision Date March 17, 2023
Days to Decision 269 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
121d slower than avg
Panel avg: 148d · This submission: 269d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GYD Device Classification - Class 2, Special Controls

Product Code GYD Transducer, Tremor
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1950
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.