Identifiers
- 510(k) Number
- K934845 FDA 510(k)
- FDA Product Code
- IMG FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 890.5860 FDA 510(k)
- Regulation Number
- 890.5860 FDA 510(k)
- Advisory Committee
- Physical Medicine FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The device is a Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat, as defined in the device specifications. It is a portable ultrasound generator designed for therapeutic deep heat application.
It is supplied as a reusable device, with a 5 cm² / 1 MHz applicator, suitable for use in physical medicine settings. The device is authorized under FDA 510(k) clearance (K934845) and is intended for use in treating narrow or angular anatomy such as hands or feet.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Sonicator 715 - Podiatry Superstore, PDF Super Sonic Transports. - CardiacDirect, METTLER ELECTRONICS ME715 Sonicator Ultrasound Generator
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K934845 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Mettler Electronics Corp.
Sources (1)
- FDA 510(k) K934845 24 fields · synced Sep 27, 2026