# K080950: Stiwell MED4

- Pathway: 510(k) (Traditional)
- Applicant: Otto Bock, Austria GmbH
- Decided: Apr 2, 2009 after 364 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: 6 generations back to K930530 (1995). 23 ancestors in all.
34 later devices descend from it; 8 cite it directly.
0 of 58 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032954: Elpha, Models II 500, II 1000, II 2000, II 3000 and E80, Danmeter A/S (2004) Summary page 2.
- K053434: Myotrac Infiniti Electrical Stimulator, Thought Technology, Ltd. (2006) Summary page 2.
- K040849: Mentamove, Cole & Associates (2004) Summary page 2.
- K940301: Compex 2, Biodex Medical Systems, Inc. (1994) Summary page 2.
- K032988: Elpha 4 Conti, Danmeter A/S (2003) Summary page 2.
- K031900: Handmaster, Ness-Neuromuscular Electrical Stimulation Systems (2003) Summary page 2.

## Most influential descendants
- K110179: Incontrol (2012), 21 descendants of its own
- K134020: Intonemv (2014), 10 descendants of its own
- K141158: APEX (2014), 9 descendants of its own
- K181497: HPM-6000UF (2018), 6 descendants of its own
- K142506: TensCare KegelFit (2015), 4 descendants of its own

## Indications for use
The STIWELL med4 is a neuromuscular electronic stimulator indicated for use under medical supervision for adjunctive therapy in the treatment of medical diseases and conditions. As a powered muscle stimulator the STIWELL med4 is indicated for the following conditions: * Relaxation of muscle spasm * Prevention or retardation of disuse atrophy * Increasing local blood circulation * Muscle re-education * Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis * Maintaining or increasing range of motion As a transcutaneous electrical nerve stimulator for pain relief the STIWELL med4 is indicated for the following conditions: * Symptomatic relief and management of chronic (long-term), intractable pain * Adjunctive treatment inthe management of post-surgical pain and post traumatic acute pain As a biofeedback device the STIWELL med4 is indicated for the following conditions: * Biofeedback, relaxation and muscle re-education purposes As an external functional neuromuscular stimulator the STIWELL med4 is indicated for the following conditions: : Helps to relearn voluntary motor functions of the extremities As a nonimplanted electrical continence device the STIWELL med4 is indicated for the following conditions: - Acute and ongoing treatment of stress, urge or mixed urinary incontinence and where the following results may improve urinary control: Inhibition of the detruser muscles through reflexive mechanisms and strengthening of pelvic floor muscles * Incontinence treatment for assessing EMG activity of the pelvic floor and accessory muscles such as the abdominal and the gluteus muscles

Source page: https://510kreport.com/device/K080950
Methodology: https://510kreport.com/methodology