# K133108: Fit Belt

- Pathway: 510(k) (Traditional)
- Applicant: Hong Qiangxing (Shenzhen) Electronics Limited
- Decided: Aug 5, 2014 after 309 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: 6 generations back to K010335 (2001). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102295: X2ABS Dual Channel Fitness Belt, Leto Enterprises Incorporation (2011) Summary page 4.
- K092476: Sport-Elec Body Control System, Model 4M, Sport-Elec (2010) Summary page 4.

## Indications for use
The SM9065 Fitness Belt is indicated for the improvement of muscle tone, for strengthening of muscles and for the development of firmer muscles. - The big belt is intended for use on the muscles in abdomen. - The small belt is intended for use on the muscles in arms and thighs areas. Contraindicated use on injured or otherwise impaired muscles. Not intended for use in any therapy or for the treatment of any medical conditions or diseases.

Source page: https://510kreport.com/device/K133108
Methodology: https://510kreport.com/methodology