# K022175: P4 Physio

- Pathway: 510(k) (Traditional)
- Applicant: Valmed Corp.
- Decided: Sep 9, 2002 after 68 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.
3 later devices descend from it; 2 cite it directly.
0 of 4 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
- K072252: Veinoplus Neuromuscular Stimulator (2008), 1 descendant of its own
- K141919: Veinoplus Sport Neuromuscular Stimulator (2015), 0 descendants of its own
- K112148: Powered Muscle Stimulator (2012), 0 descendants of its own

## Indications for use
Powered Muscle Stimulator P4-PHYSIO Electrical Muscle Stimulator (EMS) devices should only be used under advice from physician or a qualified health professional as adjunctive therapy for the treatment of medical conditions. The intended application is for stimulation of all parts of a body except head and frontal part of the neck. Specific applications include: 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; Maintaining or increasing range of motion of extremities.

Source page: https://510kreport.com/device/K022175
Methodology: https://510kreport.com/methodology
