# K102598: HI-Dow-XP

- Pathway: 510(k) (Traditional)
- Applicant: Hi-Dow International, Inc.
- Decided: May 13, 2011 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: 3 generations back to K940301 (1994). 5 ancestors in all.
78 later devices descend from it; 9 cite it directly.
0 of 84 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060846: Therapeutic Massage Companion, Endurance Therapeutics (2007) Summary page 1.
- K033122: 5000Z System (Otc), Prizm Medical, Inc. (2004) Summary page 1.
- K011880: Compex Sport, Compex S.A. (2002)

## Most influential descendants
- K122744: Prospera Otc Tens Electronic Pulse Massager (2013), 55 descendants of its own
- K121719: SM Tens & PMS (2013), 30 descendants of its own
- K133929: Health Expert Elctronic Stimulator (2014), 26 descendants of its own
- K121757: Healthmateforever (2012), 22 descendants of its own
- K143207: Revitive IX (OTC) (2015), 17 descendants of its own

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

Source page: https://510kreport.com/device/K102598
Methodology: https://510kreport.com/methodology