# K110057: Mini Masseuse

- Pathway: 510(k) (Traditional)
- Applicant: Mj Specialty Retail
- Decided: Oct 28, 2011 after 291 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: 3 generations back to K940301 (1994). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071666: Slendertone Enervive, Model 561, Bio-Medical Research Corp. (2008) Summary page 2.

## Indications for use
Mini, Model EC12-01 is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. Mini, Model EC12-01 is not intended to be used as a therapy for any medical condition. None of the Mini programs are designed for injured or ailing muscles and their use on such muscles is contraindicated.

Source page: https://510kreport.com/device/K110057
Methodology: https://510kreport.com/methodology