# K183674: Electronic Pulse Stimulator

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Leading Perfection Technology Co., Ltd.
- Decided: Oct 11, 2019 after 288 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: 7 generations back to K940301 (1994). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151035: PulseRelief, Philips Consumer Lifestyle (2015) Summary page 4.
- K171803: HIVOX OTC Electrical Stimulator, Hivox Biotek, Inc. (2017) Summary page 4.
- K133929: Health Expert Elctronic Stimulator, Shenzhen Osto Technology Company Limited (2014) Summary page 4.

## Indications for use
Mode 1 (PMS): To be used for stimulating healthy muscles in order to improve and facilitate muscle performance. Mode 2 (TENS): To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), lower extremities (leg), abdomen and bottom due to strain from exercise or normal household work activities

Source page: https://510kreport.com/device/K183674
Methodology: https://510kreport.com/methodology