# K133789: Dolphin Neurostim Otc

- Pathway: 510(k) (Traditional)
- Applicant: Acumed Medical, Ltd.
- Decided: Mar 4, 2015 after 447 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: 6 generations back to K912178 (1991). 15 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130114: Painmaster MCT Patch, Newmark, Inc. (2013) Summary page 4.
- K023726: Tens Pro 900, Acumed Medical Supplies, Ltd. (2003) Summary page 4.

## Most influential descendants
- K182671: Medi-Direct TENS Pen (2019), 0 descendants of its own

## Indications for use
The Dolphin Neurostim™ OT C is indicated for temporary relief of pain associated with sore and aching muscles in the back, arms, and legs due to strain from exercise or normal household and work activities.

Source page: https://510kreport.com/device/K133789
Methodology: https://510kreport.com/methodology