# K163393: Hi-Dow Wireless TENS/EMS System (Model HD-5N)

- Pathway: 510(k) (Traditional)
- Applicant: Hi-Dow International, Inc.
- Decided: Aug 4, 2017 after 245 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: 4 generations back to K940301 (1994). 9 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102598: HI-Dow-XP, Hi-Dow International, Inc. (2011) Summary page 4.
- K130723: FDES106 Mini Tens&Ems Device,FDES106 Multi-Function Mini Tens&Ems Device,FDES105 Pain Relief Plaster,FDES107 Abdominal, Famidoc Technology Co., Ltd. (2014) Summary page 4.

## Most influential descendants
- K241785: StarFormer (M008-3T) (2025), 0 descendants of its own

## Indications for use
TENS: To be used for the temporary relief of pain associated with sore or aching muscles in the shoulder, waist, back, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities. EMS: It is intended for muscle conditioning, used for stimulating muscles including abdomen muscles in order to improve or facilitate muscle performance.

Source page: https://510kreport.com/device/K163393
Methodology: https://510kreport.com/methodology