# K124055: T1040 Aka Aurawave

- Pathway: 510(k) (Traditional)
- Applicant: Endurance Therapeutics
- Decided: Jul 19, 2013 after 200 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
No predicates in its family tree.
5 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K150277: Pain Therapy System, Model PTS-II (2016), 3 descendants of its own
- 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
- K170205: Low-Frequency Therapy Instrument /Model: KTR-201, KTR-202, KTR-203 (2017), 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 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. To be used for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis, choose Manual modes 1 and 3 or Auto 1,Auto 2, Auto 3, 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/K124055
Methodology: https://510kreport.com/methodology