Cleared Traditional

Dexus Prosthetics System (Model: MSL1, MSR1) (K220002) - FDA 510(k) Clearance

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K220002 · Zhejiang Qiangnao Technology Co.,Ltd · Neurology device
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Sep 2022
Decision
248d
Days
Class 2
Risk

K220002 is an FDA 510(k) clearance for the Dexus Prosthetics System (Model: MSL1, MSR1). Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Zhejiang Qiangnao Technology Co.,Ltd (Hangzhou, CN). The FDA issued a Cleared decision on September 9, 2022 after a review of 248 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1320 - 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 Zhejiang Qiangnao Technology Co.,Ltd devices

Submission Details

510(k) Number K220002 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 04, 2022
Decision Date September 09, 2022
Days to Decision 248 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
100d slower than avg
Panel avg: 148d · This submission: 248d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GXY Electrode, Cutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1320
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 Consultant

Share Info (Guangzhou) Medical Consultant , Ltd.
Cassie Lee

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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