# K150078: PowerDot (R) PD-01 Muscle Stimulator (with PowerDot (R) Mobile Application)

- Pathway: 510(k) (Traditional)
- Applicant: Smartmissimo Technologies Pte, Ltd.
- Decided: Sep 30, 2015 after 258 days
- Product code: NGX (Stimulator, Muscle, Powered, For Muscle Conditioning)
- Device class: 2
- Regulation: 21 CFR 890.5850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K940301 (1994). 4 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083140: Compex Sport Plus, Chattanooga Group (2009) Summary page 4.

## Most influential descendants
- K253478: Motive™ Muscle Stimulator for Lower Back (OT01-1003) (2025), 0 descendants of its own
- K182794: BionicGym Powered Muscle Stimulator (2019), 0 descendants of its own

## Indications for use
The PowerDot PD-01 device, used with PowerDot Mobile Application, is intended for the stimulation of healthy muscles in order to improve or facilitate muscle performance. The PowerDot PD-01 device and PowerDot Mobile Application are not intended to be used in conjunction with therapy or treatment diseases of medical or medical conditions of any kind.

Source page: https://510kreport.com/device/K150078
Methodology: https://510kreport.com/methodology