Cleared Traditional

Sonomed IV, Sonomed V

K202788 · Carci Industria E Comercio DE Aparelhos Cirurgicos E Orto · Physical Medicine
Dec 2021
Decision
457d
Days
Class 2
Risk

About This 510(k) Submission

K202788 is an FDA 510(k) clearance for the Sonomed IV, Sonomed V, a Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat (Class II — Special Controls, product code IMI), submitted by Carci Industria E Comercio DE Aparelhos Cirurgicos E Orto (Sao Paulo, BR). The FDA issued a Cleared decision on December 23, 2021, 457 days after receiving the submission on September 22, 2020. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5300.

Submission Details

510(k) Number K202788 FDA.gov
FDA Decision Cleared SESE
Date Received September 22, 2020
Decision Date December 23, 2021
Days to Decision 457 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF

Device Classification

Product Code IMI — Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
Device Class Class II — Special Controls
CFR Regulation 21 CFR 890.5300