# K060846: Therapeutic Massage Companion

- Pathway: 510(k) (Traditional)
- Applicant: Endurance Therapeutics
- Decided: Dec 3, 2007 after 615 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: 2 generations back to K940301 (1994). 4 ancestors in all.
151 later devices descend from it; 11 cite it directly.
0 of 156 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011880: Compex Sport, Compex S.A. (2002) Summary page 1.
- K033122: 5000Z System (Otc), Prizm Medical, Inc. (2004) Summary page 1.
- K050174: Bio-Stim Kit, Skylark Device & Systems Co., Ltd. (2005) Summary page 1.

## Most influential descendants
- K102598: HI-Dow-XP (2011), 78 descendants of its own
- K112392: Hivox Biotek Inc. (2012), 58 descendants of its own
- K122744: Prospera Otc Tens Electronic Pulse Massager (2013), 55 descendants of its own
- K110068: Model PM3030 (2011), 50 descendants of its own
- K113037: Pain-Aid (2012), 33 descendants of its own

## Indications for use
To be used for temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household work activities choose Manual modes 1, 2, 3, 4, 5, 6 or Auto 4 To be used for temporary relief of pain associated with sore and aching muscles in the upper extremities (arm) due to strain from exercise or normal household work activities choose Manual modes 1, 2, 3, 4, 5, 6 or Auto 1 or Auto 3 To be used for temporary relief of pain associated with sore and aching muscles in the lower extremities (leg) due to strain from exercise or normal household work activities choose Manual modes 1, 2, 6 or Autol or Auto 4 Used to stimulate healthy muscles in order to improve and facilitate muscle performance choose Manual Mode 1 or Auto Mode 2

Source page: https://510kreport.com/device/K060846
Methodology: https://510kreport.com/methodology