# K182581: PlayMakar Sport Muscle Stimulator, Model PRO-500

- Pathway: 510(k) (Traditional)
- Applicant: Playmakar, Inc.
- Decided: Nov 21, 2018 after 63 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.
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
For use by healthy adults for the stimulation of healthy muscles in order to improve or facilitate muscle performance. (Choose EMS Modes P1 through P6) For temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities. (Choose TENS Modes P1 through P3) For temporary relief of pain associated with sore and aching muscles in the upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities. (Choose TENS Modes P1 through P3) For symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis. (Choose TENS Mode P4)

Source page: https://510kreport.com/device/K182581
Methodology: https://510kreport.com/methodology