# K110068: Model PM3030

- Pathway: 510(k) (Traditional)
- Applicant: Omron Healthcare, Inc.
- Decided: Dec 8, 2011 after 332 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.
50 later devices descend from it; 6 cite it directly.
0 of 56 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 3.

## Most influential descendants
- K132993: Counter Otc Tens Device (2014), 26 descendants of its own
- K150386: Tyece OTC TENS Device (2015), 24 descendants of its own
- K171803: HIVOX OTC Electrical Stimulator (2017), 21 descendants of its own
- K141978: Maxpower Relief (2014), 10 descendants of its own
- K190347: HIVOX OTC Electrical Stimulator (2019), 8 descendants of its own

## Indications for use
This device is intended for the relief of pain associated with sore or aching muscles of the lower back, arms, or legs due to strain from exercise or normal household and work activities.

Source page: https://510kreport.com/device/K110068
Methodology: https://510kreport.com/methodology