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Sign in to claim this brandEXCELHEALTH, INC.
US
Last updated May 30, 2026
What EXCELHEALTH, INC. makes
The company manufactures single-use transcutaneous electrical stimulation (TENS) electrodes and complete analgesic TENS systems designed for pain relief, including models specifically for arthritis management. These devices deliver electrical impulses through adhesive electrodes to target nerve pathways and reduce discomfort. The systems include both disposable electrodes and reusable leads for connectivity. All products are branded under the iReliev name.
The portfolio consists of Class II medical devices, regulated under the FDA’s Unique Device Identifier (UDI) system. These devices are listed in the FDA’s UDI database, ensuring traceability and compliance with U.S. regulatory requirements. The company operates from the United States, adhering to domestic medical device regulations.
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 ExcelHealth, Inc. manufacture?
ExcelHealth, Inc. specializes in transcutaneous electrical stimulation (TENS) devices. Their portfolio includes single-use TENS electrodes, reusable transcutaneous electrical stimulation leads, and complete analgesic TENS systems—including models tailored for arthritis pain relief. These devices work by delivering controlled electrical impulses through adhesive electrodes to help manage discomfort.
Where is ExcelHealth, Inc. based, and how does that affect its devices?
ExcelHealth, Inc. is based in the United States, meaning its devices are subject to U.S. medical device regulations. Since they are classified as Class II devices, they fall under FDA oversight, including requirements like the Unique Device Identifier (UDI) system, which ensures traceability and compliance with regulatory standards.
Are ExcelHealth, Inc.’s devices listed in any regulatory databases?
Yes, ExcelHealth, Inc.’s devices are included in the FDA’s Unique Device Identifier (UDI) database. This listing is mandatory for Class II devices in the U.S. and helps ensure transparency, traceability, and compliance with regulatory requirements for medical devices.
How are ExcelHealth, Inc.’s devices classified under U.S. regulations?
ExcelHealth, Inc.’s devices are classified as Class II under FDA regulations. This classification applies to devices that pose moderate risk and require special controls beyond general controls to ensure safety and effectiveness, such as TENS systems used for pain management.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- ireliev.com
- —
- —
- [email protected]
- Phone
- 406-672-6066
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 079213529
Catalogue (12)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| iReliev | ET-5050 | FDA UDI | Class II | Active |
| iReliev | CM5050 | FDA UDI | Class II | Active |
| iReliev | CM5050-4 | FDA UDI | Class II | Active |
| iReliev | ET-5555 | FDA UDI | Class II | Active |
| iReliev | ET-1515 | FDA UDI | Class II | Active |
| iReliev | ET-1313 | FDA UDI | Class II | Active |
| iReliev | ET-7171 | FDA UDI | Class II | Active |
| iReliev | ET-8080 | FDA UDI | Class II | Active |
| iReliev | ET-5252 | FDA UDI | Class II | Active |
| iReliev | ET-5454 | FDA UDI | Class II | Active |
| iReliev | ET-7070 | FDA UDI | Class II | Active |
| iReliev | ET-7272 | FDA UDI | Class II | Active |
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