# K113017: Sys*Stim 240

- Pathway: 510(k) (Abbreviated)
- Applicant: Mettler Electronics Corp.
- Decided: Jun 26, 2012 after 259 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
Longest line of descent: 5 generations back to K001179 (2000). 11 ancestors in all.
9 later devices descend from it; 3 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031077: Vectra Epr System and Intelect Epr System, Chattanooga Group (2003) Summary page 1.
- K043586: Laser Sys*Stim 540, Model ME 540, Mettler Electronics Corp. (2005) Summary page 1.

## Most influential descendants
- K223802: accufit (2023), 5 descendants of its own
- K233926: accufit (2024), 4 descendants of its own
- K241685: SofWave System (2024), 2 descendants of its own
- K250146: SofWave System (2025), 1 descendant of its own
- K213655: HiTop® (Models: HiToP®4touch, HiToP®2touch, HiToP®1touch) (2023), 1 descendant of its own

## Indications for use
1. Indications for Medium Frequency (Russian), Biphasic, High Volt Pulsed Current (HVPC), Interferential (4P) and Premodulated (2P3) waveforms * Relaxation of muscle spasms * Prevention or retardation of disuse atrophy * Increase local blood circulation * Muscle re-education * Maintaining or increasing range of motion * Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis 2. Additional indications for Microcurrent, Interferential (4P), Premodulated (2P3), Biphasic and TENS waveforms * Symptomatic relief and management of chronic, intractable pain * Post-traumatic acute pain * Post-surgical acute pain 3. Indications for DC (Direct Current) Mode *Relaxation of muscle spasm 4. The laser and cluster applicators of the Sys*Stim 240 emit infrared energy for: * .Temporary increase in local blood circulation * Temporary relief of minor muscle and joint aches, pains and stiffness *Relaxation of muscles *Temporary relief of muscle spasms *Temporary relief of minor pain and stiffness associated with arthritis

Source page: https://510kreport.com/device/K113017
Methodology: https://510kreport.com/methodology