D-Actor 200 Vibration Massage System

FDA 510(k) K173692 · Storz Medical AG

Substantially Equivalent

510(k) numberK173692

Submission

Device name
D-Actor 200 Vibration Massage System
Applicant
Storz Medical AG
Tagerwilen, CH
Received
December 1, 2017
Decision date
April 13, 2018
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
K220538DolorClast RadialISA · Traditional E.M.S Electro Medical Systems S.A07/11/2022SE
K210451OrthoGold 100ISA · Traditional Tissue Regeneration Technologies, LLC05/05/2021SE
K182682OrthoGold 100ISA · Traditional Tissue Regeneration Technologies12/21/2018SE
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
K203710Storz Medical MAGNETOLITH Muscle StimulatorIPF · Traditional 05/03/2021SE
K202112Storz Medical Duolith SD1 T-Top & Tower System with C-Actor Sepia HandpiecePZL · Traditional 02/21/2021SE

Questions and answers

When was D-Actor 200 Vibration Massage System cleared by the FDA?

D-Actor 200 Vibration Massage System (K173692) received a 510(k) decision of Substantially Equivalent on April 13, 2018, 133 days after the submission was received.

What is the product code of K173692?

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