# K202693: NeoWave Pain Relief and Recovery System, Model# T16-2020

- Pathway: 510(k) (Traditional)
- Applicant: Eva Medtec, Inc.
- Decided: Mar 5, 2021 after 171 days
- Product code: IRP (Massager, Powered Inflatable Tube)
- Device class: 2
- Regulation: 21 CFR 890.5650
- 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 K030437 (2003). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030437: Relaxor Perfect Touch Air Massaging System, Salton, Inc. (2003) Summary page 4.

## Indications for use
The NeoWave Pain Relief and Recovery System is indicated for the temporary relief of minor muscle aches and pains and for the temporary increase in circulation to the treated areas in people who are in good health. The NeoWave Pain Relief and Recovery System simulates the kneading and stroking of tissues by using inflatable air channels.

Source page: https://510kreport.com/device/K202693
Methodology: https://510kreport.com/methodology