D-Actor 200 Vibration Massage System
FDA 510(k)EUDAMEDClass I (US FDA 510(k))
Identifiers
- 510(k) Number
- K173692 FDA 510(k)
- FDA Product Code
- ISA FDA 510(k)
Classification
- Device Class
- Class I FDA 510(k)
- Legislation / Framework
- 21 CFR Part 890.5660 FDA 510(k)
- Regulation Number
- 890.5660 FDA 510(k)
- Advisory Committee
- Physical Medicine FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The D-Actor 200 Vibration Massage System is a physical medicine device designed to deliver targeted vibration therapy for muscle relaxation, pain relief, and tissue stimulation. It operates through controlled oscillatory motion to improve circulation, reduce muscle tension, and aid in rehabilitation or post-treatment recovery.
This system is intended for use in clinical, physiotherapy, or home-care settings and is supplied as a reusable medical device. It is not classified as sterile and requires proper cleaning and maintenance as per manufacturer guidelines. The device complies with FDA 510(k) clearance under the Physical Medicine category (K173692) and adheres to EU MDR and MDD directives. No MRI safety classification is specified.
Frequently asked questions
What clinical settings or environments is the D-Actor 200 Vibration Massage System intended for use in?
The D-Actor 200 is designed for use in clinical, physiotherapy, and home-care settings. Its purpose is to provide vibration therapy for muscle relaxation, pain relief, and tissue stimulation, making it suitable for rehabilitation or post-treatment recovery environments where controlled oscillatory motion can aid patient care.
Is the D-Actor 200 Vibration Massage System single-use or reusable, and what maintenance does it require?
The D-Actor 200 is a reusable medical device, meaning it is intended for repeated use across multiple patients. Since it is not sterile, it requires proper cleaning and maintenance as outlined in the manufacturer’s guidelines to ensure safe and effective operation over time.
How is the D-Actor 200 regulated, and what does its FDA clearance status indicate?
The D-Actor 200 holds FDA 510(k) clearance under the Physical Medicine category (K173692), with a decision of ‘Substantially Equivalent’ to a predicate device. This means the FDA has determined it meets the same performance standards as an existing approved device in its class, ensuring it complies with safety and effectiveness requirements for physical therapy applications.
Can the D-Actor 200 be used in proximity to MRI machines, and if not, why?
The device does not specify an MRI safety classification, which implies it has not been tested or validated for safe use in MRI environments. Clinicians should avoid using it near MRI machines unless explicit safety documentation confirms compatibility, as vibrations or metal components could pose risks in such settings.
What are the key differences between the D-Actor 200 and other vibration therapy devices in terms of regulatory compliance?
The D-Actor 200 complies with both FDA 510(k) clearance and EU MDR/Medical Device Directive (MDD) standards, ensuring it meets stringent regulatory requirements in the U.S. and European markets. Its clearance under the Physical Medicine category (K173692) specifically addresses its intended use for muscle relaxation, pain relief, and tissue stimulation, distinguishing it from non-medical massage tools or devices with different regulatory pathways.
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.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class I | Active |
| EUDAMED | European Union | MDR | — | Class I | Active |
| FDA 510(k) | United States | FDA_510K | K173692 | Class I | Active |
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Manufacturer
- Manufacturer
- Storz Medical AG
Sources (2)
- FDA 510(k) K173692 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced Jun 19, 2026