# K970131: Orthosonics Duo-Son Ultrasound Diathermy Device

- Pathway: 510(k) (Traditional)
- Applicant: C.L. Mcintosh & Assoc., Inc.
- Decided: Jun 16, 1997 after 153 days
- Product code: IMI (Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat)
- Device class: 2
- Regulation: 21 CFR 890.5300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K883228 (1988). 1 ancestor in all.
2 later devices descend 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)
- K883228: Sonicator 720 (Model ME720), Mettler Electronics Corp. (1988) Summary page 1.

## Most influential descendants
- K081075: Painshield MD (2008), 1 descendant of its own
- K221210: PainShield MD PLUS (2022), 0 descendants of its own

## Indications for use
The Orthosonics Duo-Son Ultrasound Diathermy Device is intended to apply ultrasonic energy to generate deep heat within body tissues for the treatment of selected medical conditions such as relief of pain, muscle spasms, and joint contractures.

Source page: https://510kreport.com/device/K970131
Methodology: https://510kreport.com/methodology