# K253740: Tens&Ems (HZ9151B, HZ9151C, HZ9151D)

- Pathway: 510(k) (Traditional)
- Applicant: Hong Qiangxing (Shenzhen) Electronics Limited
- Decided: Dec 23, 2025 after 29 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
TENS: The device is used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arm, leg and feet, due to strain from exercise or normal household and work activities. EMS: The device is used to stimulate healthy muscles in order to improve and facilitate muscle performance.

Source page: https://510kreport.com/device/K253740
Methodology: https://510kreport.com/methodology
