# K203525: D function

- Pathway: 510(k) (Traditional)
- Applicant: Ito Co., Ltd.
- Decided: May 5, 2021 after 155 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: 2 generations back to K842223 (1984). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031998: Model J-5 Mvo-Monitor, Myotronics-Noromed, Inc. (2003) Summary page 4.

## Most influential descendants
- K243290: BTL-785MJ (2025), 0 descendants of its own

## 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/K203525
Methodology: https://510kreport.com/methodology