# K221210: PainShield MD PLUS

- Pathway: 510(k) (Special)
- Applicant: Nanovibronix, Inc.
- Decided: Nov 23, 2022 after 210 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: 3 generations back to K883228 (1988). 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)
- K081075: Painshield MD, Nano Vibronix, Ltd. (2008) Summary page 4.

## Indications for use
The PainShield MD PLUS 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/K221210
Methodology: https://510kreport.com/methodology