# K243290: BTL-785MJ

- Pathway: 510(k) (Traditional)
- Applicant: BTL Industries, Inc.
- Decided: May 9, 2025 after 203 days
- Product code: NUW (Stimulator, Muscle, Powered, Dental)
- 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 K842223 (1984). 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)
- K203525: D function, Ito Co., Ltd. (2021) Summary page 6.

## Indications for use
The BTL-785MJ device with the controller and single-use applicators has the following indications for use: 1. To relieve symptoms associated with muscle spasm, to treat temporomandibular joint (TMJ) dysfunction and associated pain 2. Muscle re-education 3. Increasing blood flow 4. Maintain or increase mandibular range of motion

Source page: https://510kreport.com/device/K243290
Methodology: https://510kreport.com/methodology