# K181759: PowerDot PD-01MT

- Pathway: 510(k) (Abbreviated)
- Applicant: Smartmissimo Technologies Pte, Ltd.
- Decided: Nov 9, 2018 after 130 days
- Product code: IPF (Stimulator, Muscle, Powered)
- 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-01MT stimulator is a prescription device which is intended to be used following the directions of a healthcare provider. The device can be either used by the therapist in healthcare facility setting (when operated from PowerDot Doctor Mobile Application) or by patient/lay operator in a home environment (when operated from PowerDot Patient Mobile Application). PowerDot PD-01MT has the following indications for use: NMES - Retarding or preventing disuse atrophy - Maintaining or increasing range of motion - Re-educating muscles - Relaxation of muscle spasms - Increasing local blood circulation - Prevention of venous thrombosis of the calf muscles immediately after surgery - Stimulation of healthy muscles in order to improve or facilitate muscle performance TENS - Symptomatic relief and management of chronic, intractable pain - Post-surgical and post-trauma acute pain - Temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities

Source page: https://510kreport.com/device/K181759
Methodology: https://510kreport.com/methodology