# K160893: HANAROCare ReJu

- Pathway: 510(k) (Traditional)
- Applicant: M.I.Tech Co., Ltd.
- Decided: Jul 27, 2016 after 118 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). 9 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122744: Prospera Otc Tens Electronic Pulse Massager, Prospera Corporation (2013) Summary page 5.

## Most influential descendants
- K200237: Transcutaneous Electronic Nerve Stimulator (2020), 0 descendants of its own
- K170205: Low-Frequency Therapy Instrument /Model: KTR-201, KTR-202, KTR-203 (2017), 0 descendants of its own

## Indications for use
HANAROCare ReJu is indicated for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities.

Source page: https://510kreport.com/device/K160893
Methodology: https://510kreport.com/methodology