Cleared Traditional

K200636 - AXUS ES-5 Electro-Acupuncture Device (FDA 510(k) Clearance)

K200636 · Lhasa Oms, Inc. · Neurology device
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Feb 2021
Decision
330d
Days
-
Risk

K200636 is an FDA 510(k) clearance for the AXUS ES-5 Electro-Acupuncture Device. Classified as Stimulator, Electro-acupuncture (product code BWK).

Submitted by Lhasa Oms, Inc. (Weymouth, US). The FDA issued a Cleared decision on February 3, 2021 after a review of 330 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel. 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. Elevated predicate reliance profile. 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 Lhasa Oms, Inc. devices

Submission Details

510(k) Number K200636 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 2020
Decision Date February 03, 2021
Days to Decision 330 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
182d slower than avg
Panel avg: 148d · This submission: 330d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code BWK Stimulator, Electro-acupuncture
Device Class -

Regulatory Consultant

Ken Block Consulting, LLC
Saori Sawaki

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.