# K172876: PowerDot PD-01M

- Pathway: 510(k) (Special)
- Applicant: Smartmissimo Technologies Pte, Ltd.
- Decided: Dec 4, 2017 after 74 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
PowerDot PD-01M device, used with PowerDot Mobile Application, is intended for the stimulation of healthy muscles in order to improve or facilitate muscle performance. PowerDot PD-01M device and PowerDot Mobile Application is 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/K172876
Methodology: https://510kreport.com/methodology