MyOnyx System
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- MyOnyx EUDAMEDFDA UDI
- Generic Name
- Psychophysiological biofeedback system FDA UDI
- Device Name
- MyOnyx EUDAMED
- Model / Reference
- SA9020 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 07540191000593 EUDAMEDFDA UDI
- Basic UDI-DI
- B-07540191000593 EUDAMED
- FDA Product Code
- IPF FDA 510(k)FDA UDIKPI FDA UDIHCC FDA UDIGZJ FDA UDI
- EMDN Code
- N01028099,U070399,Z12062401,Z12062899 EUDAMED
- GMDN Term
- Psychophysiological biofeedback system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 890.5850 FDA 510(k)
- Regulation Number
- 890.5850 FDA 510(k)FDA UDI876.5320 FDA UDI882.5050 FDA UDI882.5890 FDA UDI
- Market of Registration
- France EUDAMED
- Advisory Committee
- Physical Medicine FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
The MyOnyx System is a powered muscle stimulation device classified as an electrical stimulator, non-implantable. It is designed to address muscle spasms, facilitate muscle re-education, prevent or slow disuse atrophy, improve range of motion, enhance local blood circulation, and reduce post-surgical venous thrombosis risk through targeted calf muscle stimulation.
The device is supplied as a reusable system and is intended for clinical use in physical medicine settings. It operates under FDA 510(k) clearance (K213197) and complies with the Medical Device Directive (MDD). No specific sterility or MRI safety information is provided in the available data, and no single-use designation is indicated.
Frequently asked questions
What clinical conditions is the MyOnyx System specifically designed to address in physical medicine settings?
The MyOnyx System is designed to address muscle spasms, facilitate muscle re-education, prevent or slow disuse atrophy, improve range of motion, and enhance local blood circulation. Additionally, it targets reducing the risk of post-surgical venous thrombosis by stimulating calf muscles. These features make it suitable for clinical use in physical medicine to support rehabilitation and mobility.
Is the MyOnyx System intended for single-use or can it be reused in clinical settings?
The MyOnyx System is explicitly described as a reusable device, meaning it is designed for repeated use in clinical settings. There is no indication in the provided data that it requires single-use disposal.
How is the MyOnyx System regulated, and what does its classification under the FDA 510(k) process mean for users?
The MyOnyx System holds FDA 510(k) clearance under the product code IPF (Intravenous Fluids, Pumps, and Infusion Devices) and was determined to be *substantially equivalent* to a legally marketed device. This means it meets FDA standards for safety and effectiveness, and clinicians can rely on its regulatory pathway as a validated electrical stimulator for physical medicine applications. It also complies with the Medical Device Directive (MDD) in Europe.
What types of environments or facilities is the MyOnyx System intended for, and why?
The MyOnyx System is explicitly intended for clinical use in physical medicine settings, such as rehabilitation clinics, physical therapy centers, or hospital-based therapy departments. Its design—including reusable components and targeted muscle stimulation—aligns with the needs of structured, professional healthcare environments focused on mobility, recovery, and postoperative care.
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. Sources consulted: PDF Thought Technology Ltd. Device Name MyOnyx, Thought Technology, K213197 FDA 510(k) - MyOnyx System | Thought Technology , Ltd., K201014 - MyOnyx System | FDA 510(k) | Thought Technology , Ltd.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K213197 | Class II | Active |
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Manufacturer
- Manufacturer
- Thought Technology Ltd.
- FDA Applicant
- Thought Technology , Ltd.
Sources (3)
- FDA 510(k) K213197 24 fields · synced Sep 18, 2026
- FDA UDI 3ee578a8-b4a5-4a35-b90b-ffc05a7a915d 33 fields · synced May 30, 2026
- EUDAMED 938708a6-f4c4-4c24-ad4a-8fc1d379b387 61 fields · synced Jul 11, 2026