# K030998: Medrelief SE Series, Models SE-50, SE-100, SE-200, SE-300

- Pathway: 510(k) (Traditional)
- Applicant: Healthonics, Inc.
- Decided: Oct 10, 2003 after 193 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: 1 generation back to K923914 (1992). 4 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980040: Electronic Muscle Stimulator - Microstim J-1304D, Nisha Communication Industries (1998) Summary page 1.
- K923914: IF-II (TM), Model 7200, Medical Devices, Inc. (1992) Summary page 1.
- K003507: Medrelief, Healthonics, Inc. (2001) Summary page 1.
- K935132: Home Microcurrent HMC, Medical Devices, Inc. (1994) Summary page 1.

## Most influential descendants
- K060669: Medrelief ST Series, Models RT-50, ST-100, ST 150, ST-200, ST-300 (2006), 2 descendants of its own
- K062616: Wellnesspro 2010 (2007), 0 descendants of its own
- K062325: RS-4I Muscle Stimulator Family (2007), 0 descendants of its own

## Indications for use
The MedRelief SE-50 and SE-100, and the MedRelief SE-200 and SE-300 in subthreshold and interferential modes, are intended for the following indications: Relief of chronic intractable pain. Adjunctive treatment of post-surgical or post-traumatic acute pain. The MedRelief SE-200 and SE-300 in muscle stimulation mode are intended for the following indications: Relaxation of muscle spasms. Prevention or retardation of disuse atrophy. Muscle re-education. Increasing local blood circulation. Maintaining or increasing range of motion Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis (SE-300 only). For the SE-200 and SE-300 in muscle stimulation mode, the lowest three intensity settings may not provide effective muscle contractions to achieve the indications for use, especially when applied to large muscles or muscle groups. These settings are provided so that the intensity may be ramped up slowly for improved user comfort.

Source page: https://510kreport.com/device/K030998
Methodology: https://510kreport.com/methodology