# K032954: Elpha, Models II 500, II 1000, II 2000, II 3000 and E80

- Pathway: 510(k) (Abbreviated)
- Applicant: Danmeter A/S
- Decided: Aug 9, 2004 after 322 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.
40 later devices descend from it; 3 cite it directly.
0 of 41 devices 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.

## Most influential descendants
- K080950: Stiwell MED4 (2009), 34 descendants of its own
- 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

## Indications for use
ELPHA 11 500, ELPHA 11 1000 This Danmeter device is designed for the symptomatic relief and management of chronic (long-term), intractable pain and an adjunctive treatment in the management of post-surgical pain and post traumatic acute pain. ELPHA 11 2000 This Danmeter device is designed for the 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 maintaining or increasing range of motion. ELPHA 11 3000 This Danmeter device is designed for: Symptomatic relief and management of chronic (long-term), intractable pain and an adjunctive treatment in the management of post-surgical pain and post traumatic acute pain. 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 maintaining or increasing range of motion.

Source page: https://510kreport.com/device/K032954
Methodology: https://510kreport.com/methodology