# K200177: Low-frequency Multi-function physiotherapy instrument

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Kentro Medical Electronics Co., Ltd.
- Decided: Mar 25, 2021 after 426 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). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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), Shenzhen Kentro Medical Electronics Co., Ltd. (2020). Cleared while this submission was under review Summary page 4.

## Indications for use
KTR-2240,KTR-2250,KTR-2610,KTR-2640,KTR-2650: (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 muscle development of firmer abdomen. KTR-2241,KTR-2251,KTR-2242,KTR-2252, KTR-2611,KTR-2641,KTR-2651,KTR-2612,KTR-2642, KTR-2652: (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/K200177
Methodology: https://510kreport.com/methodology