# K133929: Health Expert Elctronic Stimulator

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Osto Technology Company Limited
- Decided: Nov 12, 2014 after 324 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: 5 generations back to K940301 (1994). 10 ancestors in all.
26 later devices descend from it; 15 cite it directly.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121719: SM Tens & PMS, Hong Qiangxing (Shenzhen) Electronics Limited (2013) Summary page 4.
- K122744: Prospera Otc Tens Electronic Pulse Massager, Prospera Corporation (2013) Summary page 4.

## Most influential descendants
- K190783: Health Expert Electronic Stimulator (model: AST-300L) (2020), 6 descendants of its own
- K172897: Neck Care Therapy, Model: SYK 509B (2018), 3 descendants of its own
- K191982: Low-Frequency Multi-function Physiotherapy Instrument (Model: KTR-2230, KTR-2220, KTR-2210, KTR-2231, KTR-2221, KTR-2211, KTR-2232, KTR-2222, KTR-2212) (2020), 2 descendants of its own
- K163611: Pain Therapy Device (2017), 2 descendants of its own
- K211942: Heating Lumbar Therapy Cushion (Model: AST-622, AST-622B, AST-623, AST-623B) (2021), 1 descendant of its own

## Indications for use
PMS (Mode 1~8) It is intended to stimulate healthy muscles in order to improve and facilitate muscle performance. TENS (Mode 9~25) To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, back of the neck, arm, leg, and foot due to strain from exercise or normal household work activities by applying current to stimulate nerve.

Source page: https://510kreport.com/device/K133929
Methodology: https://510kreport.com/methodology