# K213788: TENS&EMS STIMULATOR (Model: KRES100D, KRES1010, KRES1020, KRES1080)

- Pathway: 510(k) (Traditional)
- Applicant: Dongguan Bohuikang Technology Co.,Ltd
- Decided: May 6, 2022 after 151 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
TENS & EMS STIMULATOR has two functions and can be used for arm, shoulder, neck, back, waist, abdomen, hip, and leg. TENS: It is used for the symptomatic relief of chronic intractable pain and the temporary relief of pain associated with sore and aching muscles in the arm, shoulder, neck, back, waist, abdomen, hip and leg due to strain from exercise or normal household and work activities. EMS: It is used for relaxation of muscle spasm, increase of local blood flow circulation, prevention or retardation of disuse atrophy, muscle re-education, maintaining or increasing range of motion, and immediate post-surgical stimulation of calf muscles to prevent venous thrombosis

Source page: https://510kreport.com/device/K213788
Methodology: https://510kreport.com/methodology