# K163165: AM-100

- Pathway: 510(k) (Traditional)
- Applicant: BTL Industries, Inc.
- Decided: Feb 16, 2017 after 98 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 K062439 (2007). 2 ancestors in all.
23 later devices descend from it; 2 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131291: Torc Body, Johari Digital Healthcare, Ltd. (2013) Summary page 4.

## Most influential descendants
- K180813: BTL 799-2 (2018), 21 descendants of its own
- K182106: BTL 799-2T (2018), 12 descendants of its own
- K190456: BTL 799-2L (2019), 11 descendants of its own
- K200382: BTL-703-2 (2021), 4 descendants of its own
- K182963: emFieldPro (2019), 3 descendants of its own

## Indications for use
AM-100 is indicated to be used for: Improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer abdomen. Strengthening, Toning and Firming of buttocks and thighs.

Source page: https://510kreport.com/device/K163165
Methodology: https://510kreport.com/methodology