# K150277: Pain Therapy System, Model PTS-II

- Pathway: 510(k) (Traditional)
- Applicant: Counter Scientific Development (Gz), Ltd.
- Decided: Feb 12, 2016 after 372 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: 1 generation back to K124055 (2013). 1 ancestor in all.
3 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K124055: T1040 Aka Aurawave, Endurance Therapeutics (2013) Summary page 4.

## Most influential descendants
- K163611: Pain Therapy Device (2017), 2 descendants of its own
- K230443: TENS & EMS Device (LY-ET-01, LY-ET-02, LY-ET-04) (2023), 0 descendants of its own
- K200237: Transcutaneous Electronic Nerve Stimulator (2020), 0 descendants of its own

## Indications for use
To be used for temporary relief of pain associated with sore and aching muscles in the upper and lower back due to strain from exercise or normal household work activities (Choose Mode A, B, or C) To be used for temporary relief of pain associated with sore and aching muscles in the upper extremities (Arms) due to strain from exercise or normal household work activities (Choose Mode A, B or C) To be used for temporary relief of pain associated with sore and aching muscles in the lower extremities (Legs) due to strain from exercise or normal household work activities (Choose Mode A, B or C) To be used for symptomatic relief and management of chronic, intractable pain and relief of pain associated with Arthritis (Choose Mode A) To stimulate healthy muscles in order to improve and facilitate muscle performance (Choose Mode B)

Source page: https://510kreport.com/device/K150277
Methodology: https://510kreport.com/methodology