Cleared Traditional

K261131 - Electrical Muscle Stimulator (AST-105DJ, AST-105EJ, AST- 105BJ, AST-105GJ, AST-303J, AST-309J, AST-310J

Also marketed or referenced as:
AST-300Q, AST-300Q-A, AST-500B AST-500G, AST-500F AST-500N AST- 500C, AST- 500K, AST-500A AST-300E, AST-500M, AST- 500U, AST- 500D AST- 500E.)

K261131 is an FDA 510(k) clearance for Electrical Muscle Stimulator (AST-105DJ, manufactured by Shenzhen Osto Medical Technology Co.,Ltd. The device is a Class 2 Neurology device with product code NUH cleared through the Traditional 510(k) pathway after a 153-day FDA review.

K261131 · Shenzhen Osto Medical Technology Co.,Ltd · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2026
Decision
153d
Days
Class 2
Risk

K261131 is an FDA 510(k) clearance for the Electrical Muscle Stimulator (AST-105DJ, AST-105EJ, AST- 105BJ, AST-105GJ, AS.... Classified as Stimulator, Nerve, Transcutaneous, Over-the-counter (product code NUH), Class II - Special Controls.

Submitted by Shenzhen Osto Medical Technology Co.,Ltd (Shenzhen, CN). The FDA issued a Cleared decision on September 6, 2026 after a review of 153 days - an extended review 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: 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 Shenzhen Osto Medical Technology Co.,Ltd devices

FDA 510(k) Submission Details - K261131

510(k) Number K261131 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 2026
Decision Date September 06, 2026
Days to Decision 153 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
4d slower than avg
Panel avg: 149d · This submission: 153d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NUH Device Classification - Class 2, Special Controls

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

Guangdong Jianda Medical Technology Co., Ltd.
Jett 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 228
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