# 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.)

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Osto Medical Technology Co.,Ltd
- Decided: Sep 6, 2026 after 153 days
- Product code: NUH (Stimulator, Nerve, Transcutaneous, Over-The-Counter)
- Device class: 2
- Regulation: 21 CFR 882.5890
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
: 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.

Source page: https://510kreport.com/device/K261131
Methodology: https://510kreport.com/methodology