DolorClast Radial

FDA 510(k) K220538 · E.M.S Electro Medical Systems S.A

Substantially Equivalent

510(k) numberK220538

Submission

Device name
DolorClast Radial
Applicant
E.M.S Electro Medical Systems S.A
Nyon, CH
Received
February 25, 2022
Decision date
July 11, 2022
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
ISA – Massager, Therapeutic, Electric
Device class
Class I (low risk)
Regulation
21 CFR 890.5660
Specialty
Physical Medicine

Other 510(k)s with product code ISA

510(k)DeviceApplicantDecision
K243488Vmat ProISA · Traditional Termosalud02/06/2025SE
K240358ShockPhysio Mobile (model SW3200 Basic)ISA · Traditional Shenzhen Dongdixin Technology Co., Ltd.06/05/2024SE
K221865BTL-094ISA · Traditional BTL Industries, Inc.04/14/2023SE
K210166Omnispec ED1000ISA · Traditional Medispec, Ltd.01/27/2023SE
K213120OW100S (model OW100S-US)ISA · Traditional Tissue Regeneration Technologies, LLC Dba AS…10/12/2022SE
K210451OrthoGold 100ISA · Traditional Tissue Regeneration Technologies, LLC05/05/2021SE
K182682OrthoGold 100ISA · Traditional Tissue Regeneration Technologies12/21/2018SE
K173692D-Actor 200 Vibration Massage SystemISA · Traditional Storz Medical AG04/13/2018SE
K053225Cellu M6 Keymodule IISA · Traditional Lpg One, Inc.11/06/2006SE
K030876Cynosure Triactive Therapeutic Massage SystemISA · Traditional Cynosure, Inc.01/22/2004SE

More from Cynosure, Inc.

510(k)DeviceDecision
K253254GBT Machine Airflow Prophylaxis MasterELC · Traditional 01/28/2026SE
K243279DOLORCLAST Focused Shock WavesPZL · Traditional 08/13/2025SE
K230893Swiss LthoClast TrilogyFEO · Traditional 10/23/2023SE
K190124EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW OneELC · Traditional 10/20/2019SE
K191079Piezon Built-in Kit, Piezon Built-in Kit LEDELC · Traditional 08/16/2019SE
K191124Swiss LithoClast TrilogyFFK · Special 05/29/2019SE
K182490Swiss LithoClast TrilogyFEO · Special 10/09/2018SE
K181997Swiss LithoClast TrilogyFEO · Special 08/30/2018SE
K181364Swiss LithoClast TrilogyFEO · Special 06/20/2018SE
K173234Swiss LithoClast TrilogyFEO · Traditional 01/10/2018SE

Questions and answers

When was DolorClast Radial cleared by the FDA?

DolorClast Radial (K220538) received a 510(k) decision of Substantially Equivalent on July 11, 2022, 136 days after the submission was received.

What is the product code of K220538?

The FDA product code is ISA – Massager, Therapeutic, Electric, a Class I (low risk) device regulated under 21 CFR 890.5660.