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Sign in to claim this brandEVERYWAY MEDICAL INSTRUMENTS CO., LTD.
US
Last updated May 24, 2026
What EVERYWAY MEDICAL INSTRUMENTS CO., LTD. makes
Everyway Medical Instruments Co., Ltd. manufactures physical therapy devices, including transcutaneous neuromuscular electrical stimulation systems like the iSTIM and Pain Management units, reusable transcutaneous electrical stimulation electrodes, and perineal orifice incontinence-control electrical stimulation probes. Their portfolio also includes massage tables, traction systems (both vertical non-powered and static/intermittent powered mobile units), general-purpose stools or chairs, and traction system belts for therapeutic use.
The company’s devices are regulated under FDA classifications, with products falling into Class I and Class II categories. These devices are listed in the FDA’s 510(k) and UDI registries, ensuring compliance with U.S. medical device regulations. The manufacturer is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Everyway Medical Instruments Co., Ltd. primarily manufacture?
Everyway Medical Instruments Co., Ltd. specializes in physical therapy devices. Their portfolio includes transcutaneous neuromuscular electrical stimulation systems (like the iSTIM and Pain Management units), reusable electrodes for electrical stimulation, perineal incontinence-control probes, massage tables, traction systems (both powered and non-powered), general-purpose stools or chairs, and traction belts. These devices are designed for therapeutic applications such as pain management, muscle stimulation, and rehabilitation.
Where is Everyway Medical Instruments Co., Ltd. based, and how does this affect its regulatory standing?
Everyway Medical Instruments Co., Ltd. is based in the United States. Since the company operates within the U.S., its devices are subject to FDA regulations. The FDA classifies their products as either Class I or Class II, depending on risk levels, and these devices are listed in the FDA’s 510(k) and UDI registries to ensure compliance with U.S. medical device requirements.
Which regulatory registries list Everyway Medical Instruments Co., Ltd.’s devices, and why is this important?
Everyway Medical Instruments Co., Ltd.’s devices are listed in the FDA’s 510(k) and UDI (Unique Device Identification) registries. The 510(k) process demonstrates that a device is substantially equivalent to a legally marketed predicate device, while UDI ensures traceability and transparency in the supply chain. Listing in these registries helps verify compliance with U.S. regulatory standards for medical devices.
How are Everyway Medical Instruments Co., Ltd.’s devices classified under FDA regulations?
Everyway Medical Instruments Co., Ltd.’s devices are classified under FDA regulations as either Class I or Class II. Class I devices generally pose the lowest risk and may be exempt from some regulatory controls, while Class II devices require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use, potential risks, and the body area it interacts with, ensuring appropriate oversight.
What does it mean for a device to be listed in the FDA’s 510(k) and UDI registries?
Being listed in the FDA’s 510(k) registry means the device has undergone a premarket submission process to show it is substantially equivalent to a previously approved device, ensuring it meets safety and performance standards. Listing in the UDI registry means the device has a unique identifier, which helps track its distribution, reduce medical errors, and improve post-market surveillance. Together, these registries provide transparency and compliance verification for authorized devices.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 657383535
Catalogue (202)
Page 1 of 5| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| iSTIM | iSTIM EV-820 | FDA UDI | Class II | Active |
| Pain Management | FA3360 | FDA UDI | Class II | Active |
| Everyway4all | SA16 | FDA UDI | Class II | Active |
| Lifecare | PR-20K | FDA UDI | Class II | Active |
| Everyway | KF75D | FDA UDI | Class II | Active |
| Lifecare | PR-06 | FDA UDI | Class II | Active |
| Lifecare | PR-14K | FDA UDI | Class II | Active |
| Everyway | PR-14A | FDA UDI | Class II | Active |
| Lifecare | PR-04K | FDA UDI | Class II | Active |
| Everyway | EV-804 (Li-battery) | FDA UDI | Class II | Active |
| Balego | Balego EV-805 | FDA UDI | Class II | Active |
| Everyway | SG5050 | FDA UDI | Class II | Active |
| Lifecare | PR-06A | FDA UDI | Class II | Active |
| Everyway4all | ET8008 | FDA UDI | Class I | Active |
| Everyway | EM-6100 | FDA UDI | Class II | Active |
| Everyway | TKF50100V | FDA UDI | Class II | Active |
| Everyway | N607-1A | FDA UDI | Class II | Active |
| Lifecare | PR-20A | FDA UDI | Class II | Active |
| Lifecare | PR-03K | FDA UDI | Class II | Active |
| Everyway4all | ET8002 | FDA UDI | Class I | Active |
| Everyway | EV-806 | FDA UDI | Class II | Active |
| Lifecare | PR-03 | FDA UDI | Class II | Active |
| Everyway | TKF5050 | FDA UDI | Class II | Active |
| Pain Management | FA2020 | FDA UDI | Class II | Active |
| Everyway4all | CA130 | FDA UDI | Class I | Active |
| Everyway | S80120 | FDA UDI | Class II | Active |
| Liberty | TENS 3 | FDA UDI | Class II | Active |
| iSTIM | iSTIM PR-02A | FDA UDI | Class II | Active |
| iSTIM | iSTIM X1 | FDA UDI | Class II | Active |
| Lifecare | PR-02A | FDA UDI | Class II | Active |
| Everyway | TKF75D | FDA UDI | Class II | Active |
| Everyway | PR-09A | FDA UDI | Class II | Active |
| Everyway4all | EU25 | FDA UDI | Class I | Active |
| Medi-Stim | ComfyTENSPlus | FDA UDI | Class II | Active |
| Everyway | N601 | FDA UDI | Class II | Active |
| Everyway | N103A | FDA UDI | Class II | Active |
| Everyway | AF100152 | FDA UDI | Class II | Active |
| Everyway4all | CA65H | FDA UDI | Class I | Active |
| Everyway4all | CT-800 | FDA UDI | Class I | Active |
| Lifecare | PR-02V-1 | FDA UDI | Class II | Active |
| Everyway4all | CA190 | FDA UDI | Class I | Active |
| Lifecare | PR-20H | FDA UDI | Class II | Active |
| Lifecare | PR-04 | FDA UDI | Class II | Active |
| Everyway | SG4040 | FDA UDI | Class II | Active |
| Everyway | EM-6300 | FDA UDI | Class II | Active |
| iSTIM | iSTIM EM-5200 | FDA UDI | Class II | Active |
| Everyway | TKF4040 | FDA UDI | Class II | Active |
| Medi-Stim | CSK-O | FDA UDI | Class II | Active |
| Everyway | N605 | FDA UDI | Class II | Active |
| Pain Management | NW2500 | FDA UDI | Class II | Active |
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Everyway Medical Instruments Co., Ltd. NEW TAIPEI CITY · TW FEI 3002552319