# K013212: Wavelenght Ultrasound Lotion

- Pathway: 510(k) (Traditional)
- Applicant: National Therapy Products, Inc.
- Decided: Feb 25, 2002 after 153 days
- Product code: MUI (Media, Coupling, Ultrasound)
- 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 Ultrasound Lotion is a conductive medium for use in diagnostic and therapeutic ultrasound procedures. This device is intended to be used as an accessory to ultrasonic transducers and ultrasound monitors. Apply Wavelength to treatment area. Remove after treatment with tissue or towel. Clean equipment and rinse towels after use. For external use only. Contraindications: Not for use with defibrillators

Source page: https://510kreport.com/device/K013212
Methodology: https://510kreport.com/methodology