Cleared Traditional

Low-frequency Stimulator (Model: AST-645, AST-646) (K212989) - FDA 510(k) Clearance

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

K212989 · Shenzhen Osto Technology Co., Ltd. · Neurology device
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Nov 2021
Decision
63d
Days
Class 2
Risk

K212989 is an FDA 510(k) clearance for the Low-frequency Stimulator (Model: AST-645, AST-646). Classified as Stimulator, Nerve, Transcutaneous, Over-the-counter (product code NUH), Class II - Special Controls.

Submitted by Shenzhen Osto Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on November 22, 2021 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5890 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Shenzhen Osto Technology Co., Ltd. devices

Submission Details

510(k) Number K212989 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 2021
Decision Date November 22, 2021
Days to Decision 63 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
85d faster than avg
Panel avg: 148d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NUH Stimulator, Nerve, Transcutaneous, Over-the-counter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5890
Definition Temporary Relief Of Pain Due To Sore/aching Muscles
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

Guangzhou GLOMED Biological Technology Co., 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.

Regulatory Peers - NUH Stimulator, Nerve, Transcutaneous, Over-the-counter

All 133
Devices cleared under the same product code (NUH) and FDA review panel - the closest regulatory comparables to K212989.
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