510(k) · Cleared

Cleared

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

K261131510(k) TraditionalCleared Sep 6, 2026153-day reviewClass II21 CFR 882.5890

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Shenzhen Osto Medical Technology Co.,Ltd · NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter

Cleared on Sep 6, 2026 after a 153-day review. FDA’s file for it is a 510(k) statement, which names no predicate.

Decided: Sep 6, 2026
Review: 153 days
Class: Class II
Product code: NUH
Recalls: None
Predicates: 0

FDA’s file for it is a 510(k) statement, which names no predicate.

FIG. 1 — Lineage of K261131Source: FDA 510(k) database · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in NUH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new NUH device

#1 K190783 Health Expert Electronic Stimulator (model…score 15.8 · 7 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

How does its category compare?

All NUH devices

NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.

FDA decisions per year · NUH

15in 2025

2007high 20 (2022) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NUH

119in 2025

2007high 231 (2011) · low 90 (2024)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · NUH

No recall names NUH since 2007.

Adverse event reports per year · NUH

7in 2025

2007high 21 (2017) · low 0 (2007)2025

MAUDE reports naming product code NUH, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	4	161	0
2008	0	—	0
2009	1	—	0
2010	3	148	0
2011	6	231	0
2012	6	170	0
2013	10	189	1
2014	16	212	9
2015	14	198	11
2016	13	145	13
2017	17	155	21
2018	16	121	18
2019	19	213	5
2020	14	147	8
2021	14	198	7
2022	20	103	2
2023	15	127	4
2024	20	90	7
2025	15	119	7
2026	5	137	—

What is it indicated for?

: 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: EMS: It is intended to stimulate healthy muscles in order to improve and facilitate muscle performance. TENS: To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arm, leg and foot due to strain from exercise or normal household work activities by…

Read the full statement (116 words)

: 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:

EMS: It is intended to stimulate healthy muscles in order to improve and facilitate muscle performance.

TENS: To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arm, leg and foot due to strain from exercise or normal household work activities by applying current to stimulate nerves.

For AST-105DJ, AST-105EJ, AST- 105BJ, AST-105GJ, AST-303J, AST-309J, AST-310J:

TENS: To be used for temporary relief of pain associated with sore and aching muscles in the foot due to strain from exercise or normal household work activities by applying current to stimulate nerves.

Indications for use as stated in the FDA 510(k) statement.

https://510kreport.com/device/K261131 · printed Nov 6, 2026

Cite this page

510(k) Report. “K261131: Electrical Muscle Stimulator (AST-105DJ, AST-105EJ, AST- 105BJ, AST-105GJ, AST-303J, AST-309J, AST-310J;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.).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261131

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Record history

FDA decision record loaded Oct 30, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Page last updated Nov 3, 2026