# K202470: Li-Battery powered OTC TENS/EMS, model EM-6000, EM-6100, EM-6200 & EM-6300

- Pathway: 510(k) (Traditional)
- Applicant: Everyway Medical Instruments Co.,Ltd
- Decided: Nov 25, 2020 after 89 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 (For model EM-6000, EM-6100 & EM-6300) : intended for temporary relief of pain associated with sore and aching muscles in the low back as well as upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities. (Choose TENS B/N/M/S1/S2 adjustable mode & TENS Modes P1 to P6 for EM-6300). EMS (For model EM-6000, EM-6200 & EM-6300): intended to stimulate healthy muscles in order to improve or facilitate muscle performance. (Choose EMS C/S/A adjustable mode & EMS Modes P7 to P12 for EM-6300).

Source page: https://510kreport.com/device/K202470
Methodology: https://510kreport.com/methodology