# K071666: Slendertone Enervive, Model 561

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Medical Research Corp.
- Decided: Mar 12, 2008 after 268 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.
4 later devices descend from it; 4 cite it directly.
0 of 7 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)

## Most influential descendants
- K110057: Mini Masseuse (2011), 0 descendants of its own
- K102926: Gemore Muscle Conditioner; (2011), 0 descendants of its own
- K102786: Well-Life Otc Ems System (2011), 0 descendants of its own
- K083164: System-Arms, Models 390, X60 (2008), 0 descendants of its own

## Indications for use
"EnerViveTM" is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. "EnerViveTw" is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. None of the "EnerViveTm" training programs are designed for injured or ailing muscles and it's use on such muscles is contraindicated. The "EnerViveTW' electrical impulses allow triggering action potentials on motoneurones of motor nerves (excitations). These excitations of motoneurones are transmitted to the muscle fibers via the motor endplate where they generate mechanical muscle fiber responses that correspond to muscle work. Depending on the parameters of the electrical impulses (pulse frequency, duration of contraction, duration of rest, total session duration), different types of muscle work can be imposed on the stimulated muscles. The various types of muscle work that "EnerViveT"' can impose on the stimulated muscles are able to improve or facilitate muscle performance. "EnerViveTr" may therefore be considered a technique of muscle training.

Source page: https://510kreport.com/device/K071666
Methodology: https://510kreport.com/methodology