# K170205: Low-Frequency Therapy Instrument /Model: KTR-201, KTR-202, KTR-203

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Kentro Medical Electronics Co., Ltd.
- Decided: May 11, 2017 after 108 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). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 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 4.
- K124055: T1040 Aka Aurawave, Endurance Therapeutics (2013) Summary page 4.
- K150386: Tyece OTC TENS Device, Tyece, Ltd. (2015) Summary page 4.
- K160893: HANAROCare ReJu, M.I.Tech Co., Ltd. (2016) Summary page 4.

## Indications for use
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arm, leg and foot, due to strain from exercise or normal household and work activities

Source page: https://510kreport.com/device/K170205
Methodology: https://510kreport.com/methodology