# K081075: Painshield MD

- Pathway: 510(k) (Traditional)
- Applicant: Nano Vibronix, Ltd.
- Decided: Aug 22, 2008 after 128 days
- Product code: PFW (Stationary Ultrasonic Diathermy Device 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: 2 generations back to K883228 (1988). 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)
- K970131: Orthosonics Duo-Son Ultrasound Diathermy Device, C.L. Mcintosh & Assoc., Inc. (1997) Summary page 1.

## Most influential descendants
- K221210: PainShield MD PLUS (2022), 0 descendants of its own

## Indications for use
The PainShield™ MD diathermy device is intended to apply ultrasounic 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/K081075
Methodology: https://510kreport.com/methodology