# K161551: TR-100

- Pathway: 510(k) (Traditional)
- Applicant: BTL Industries, Inc.
- Decided: Sep 13, 2016 after 102 days
- Product code: PBX (Massager, Vacuum, Radio Frequency Induced Heat)
- Device class: 2
- Regulation: 21 CFR 878.4400
- 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 K122389 (2012). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143040: Exilis XP, BTL Industries, Inc. (2015) Summary page 4.

## Most influential descendants
- K190023: BTL-084 (2019), 0 descendants of its own

## Indications for use
The TR-100 device is intended to provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. The TR-100 massage device is intended to provide a temporary reduction in the appearance of cellulite.

Source page: https://510kreport.com/device/K161551
Methodology: https://510kreport.com/methodology