Cleared Traditional

DolorClast Radial

K220538 · E.M.S Electro Medical Systems S.A · Physical Medicine
Jul 2022
Decision
136d
Days
Class 1
Risk

About This 510(k) Submission

K220538 is an FDA 510(k) clearance for the DolorClast Radial, a Massager, Therapeutic, Electric (Class I — General Controls, product code ISA), submitted by E.M.S Electro Medical Systems S.A (Nyon, CH). The FDA issued a Cleared decision on July 11, 2022, 136 days after receiving the submission on February 25, 2022. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5660.

Submission Details

510(k) Number K220538 FDA.gov
FDA Decision Cleared SESE
Date Received February 25, 2022
Decision Date July 11, 2022
Days to Decision 136 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF

Device Classification

Product Code ISA — Massager, Therapeutic, Electric
Device Class Class I — General Controls
CFR Regulation 21 CFR 890.5660