# K221092: Transcutaneous Electrical Nerve Stimulator Model: ST-304

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Future Electronic Co., Ltd.
- Decided: Sep 13, 2022 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
Longest line of descent: 9 generations back to K940301 (1994). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210756: Neck Care Therapy, Model: AST-905A, AST-905D, AST-905H, Shenzhen Osto Technology Company Limited (2021) Summary page 5.
- K172897: Neck Care Therapy, Model: SYK 509B, Shenzhen Osto Technology Co., Ltd. (2018) Summary page 5.

## Indications for use
To be used for temporary relief of pain associated with sore and aching muscles in the back of neck, due to strain from exercise or normal household and work activities. - Neck Pad is used in back of neck.

Source page: https://510kreport.com/device/K221092
Methodology: https://510kreport.com/methodology