# K182671: Medi-Direct TENS Pen

- Pathway: 510(k) (Traditional)
- Applicant: Jkh USA, LLC
- Decided: Sep 21, 2019 after 360 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). 35 ancestors in all.
No later device cites it as a predicate yet.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162517: Electronic Pulse Stimulator Model: PL-029K12 and PL-029K13, Jkh Health Co., Ltd. (2017) Summary page 4.
- K141260: Electronic Pulse Stimulator, Shenzhen Jingkehui Electronic Co.., Ltd. (2014) Summary page 4.
- K133789: Dolphin Neurostim Otc, Acumed Medical, Ltd. (2015) Summary page 4.

## Indications for use
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arm, and leg, due to strain from exercise or normal household and work activities.

Source page: https://510kreport.com/device/K182671
Methodology: https://510kreport.com/methodology