# K230024: HI-Emt Magshape

- Pathway: 510(k) (Traditional)
- Applicant: Beijing Sano Laser S&T Development Co.,Ltd
- Decided: Sep 6, 2023 after 245 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: 8 generations back to K010335 (2001). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190456: BTL 799-2L, BTL Industries, Inc. (2019) Summary page 5.

## Indications for use
• Improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer abdomen. • Strengthening, Toning and Firming of buttocks, thighs and calves. • Improvement of muscle tone and firmness, for strengthening muscles in arms.

Source page: https://510kreport.com/device/K230024
Methodology: https://510kreport.com/methodology