# K012522: Wavelength Multi-Purpose Ultrasound Gel

- Pathway: 510(k) (Traditional)
- Applicant: National Therapy Products, Inc.
- Decided: Oct 18, 2001 after 73 days
- Product code: ITX (Transducer, Ultrasonic, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 892.1570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Wavelength Multi-Purpose Ultrasound Gel is intended to be used as a coupling medium for ultrasound transmission. Apply Wavelength to the area to be treated before treatment with ultrasound. Clean skin and ultrasound transducer immediately after use. For external use only. Not for use with defibrillator.

Source page: https://510kreport.com/device/K012522
Methodology: https://510kreport.com/methodology