# K202866: TENS & EMS Device

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Jian Feng Electronic Technology Co., Ltd.
- Decided: May 19, 2021 after 233 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). 10 ancestors in all.
3 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)
- K171803: HIVOX OTC Electrical Stimulator, Hivox Biotek, Inc. (2017) Summary page 4.
- (no number) JQ-5C: named in the summary without a submission number

## Most influential descendants
- K213741: TENS & EMS DEVICE (Model: FM-B2403A) (2022), 1 descendant of its own
- K243131: Triathlon Pro (2025), 0 descendants of its own
- K213835: TENS & EMS Device (2022), 0 descendants of its own

## Indications for use
TENS: The device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), lower extremities (leg), abdomen and bottom due to strain from exercise or normal household work activities. EMS: The device is designed to be used to stimulate healthy muscles in order to improve or facilitate muscle performance.

Source page: https://510kreport.com/device/K202866
Methodology: https://510kreport.com/methodology