# K020478: Electromedicarin 900

- Pathway: 510(k) (Abbreviated)
- Applicant: Electromedicarin, S.A.
- Decided: Jul 17, 2003 after 519 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. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K000808: Rich-Mar Winner ST4 Muscle Stimulator, Interferential, and Tens Device, Rich-Mar Corp. (2000). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
This device is an electrically powered device intended for medical purposes to repeatdly contracts muscles by passing electrical currents through electrodes contacting the affected area (21 CFR 890.5850) for the following indications for use: relaxation of muscle spasms; prevention or retardation of disuse atrophy; increasing local blood circulation; muscle re-education; immediate post-surgical stimulation of calf muscles to prevent venous thrombosis; and maintaning or increasing range of motion

Source page: https://510kreport.com/device/K020478
Methodology: https://510kreport.com/methodology