# 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)

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Kentro Medical Electronics Co., Ltd.
- Decided: Sep 25, 2020 after 428 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: 6 generations back to K940301 (1994). 11 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133929: Health Expert Elctronic Stimulator, Shenzhen Osto Technology Company Limited (2014) Summary page 5.

## Most influential descendants
- K240292: Transcutaneous Electrical Nerve Stimulator (9029SCM) (2024), 0 descendants of its own
- K200177: Low-frequency Multi-function physiotherapy instrument (2021), 0 descendants of its own

## Indications for use
KTR-2210, KTR-2220, KTR-2230:（TENS, EMS, FITNESS） TENS (Mode1~20): 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. EMS (Mode 21~40): It is intended to stimulate healthy muscles in order to improve and facilitate muscle performance. FITNESS (Mode 41~50): Improvement of abdominal tone, strengthening of the abdominal muscles development of firmer abdomen. KTR-2211, KTR-2221, KTR-2231, KTR-2212, KTR-2222, KTR-2232: (TENS) 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/K191982
Methodology: https://510kreport.com/methodology