# K031611: P4-Fitness

- Pathway: 510(k) (Traditional)
- Applicant: Valmed Corp.
- Decided: Sep 29, 2004 after 496 days
- Product code: NGX (Stimulator, Muscle, Powered, For Muscle Conditioning)
- 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: 2 generations back to K940301 (1994). 2 ancestors in all.
5 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)
- K011880: Compex Sport, Compex S.A. (2002) Summary page 1.

## Most influential descendants
- K111476: Contour Technology Muscle Stimulator (2012), 4 descendants of its own
- K130074: Gymform Abs-a-Round (2013), 3 descendants of its own
- K142055: Gymform Abs & Core (2015), 1 descendant of its own
- K202653: Gymform Total ABS (2021), 0 descendants of its own
- K181728: Muscle Trainer (2018), 0 descendants of its own

## Indications for use
The P4-Fitness is intended for stimulation of healthy muscles in order to enhance and facilitate improved muscle performance. The P4-Fitness is therefore properly considered as a technique or method for muscle training. The P4-Fitness is NOT intended for use in any therapy or for the treatment of any medical conditions or diseases. The P4-Fitness training programs are not designed or intended for injured or otherwise impaired muscles and use of the P4-Fitness on such muscles is contraindicated.

Source page: https://510kreport.com/device/K031611
Methodology: https://510kreport.com/methodology