Cleared Traditional

K220002 - Dexus Prosthetics System (Model: MSL1

K220002 is an FDA 510(k) clearance for Dexus Prosthetics System (Model: MSL1, manufactured by Zhejiang Qiangnao Technology Co.,Ltd. The device is a Class 2 Neurology device with product code GXY cleared through the Traditional 510(k) pathway after a 248-day FDA review.

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

FDA 510(k) Submission Details - K220002

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.

GXY Device Classification - Class 2, Special Controls

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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