# K181207: Balego TENS Digital Edition with Accessories for Pain Relief (OTC)

- Pathway: 510(k) (Special)
- Applicant: Everyway Medical Instruments Co., Ldt.
- Decided: Jun 6, 2018 after 30 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: 1 generation back to K172919 (2018). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172919: EV-804 OTC Pain Relief TENS, Everyway Medical Instruments Co.,Ltd (2018) Summary page 4.

## Indications for use
The Balego™ TENS Digital Edition with Accessories for Pain Relief (OTC) is 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.

Source page: https://510kreport.com/device/K181207
Methodology: https://510kreport.com/methodology