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Sign in to claim this brandBio Medical Innovations
US
Last updated May 24, 2026
What Bio Medical Innovations makes
Bio Medical Innovations manufactures single-use transcutaneous electrical stimulation (TENS) electrodes designed for temporary skin attachment during neuromuscular or pain management therapies. These electrodes are intended for disposable use in clinical and home settings, adhering to the body’s surface to deliver electrical impulses for therapeutic purposes.
The company’s product portfolio is classified under FDA’s Class II medical devices and is registered in the FDA’s Unique Device Identification (UDI) system. The devices are listed under the relevant regulatory framework 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 Bio Medical Innovations manufacture?
Bio Medical Innovations specializes in single-use transcutaneous electrical stimulation (TENS) electrodes. These electrodes are designed for temporary attachment to the skin to deliver electrical impulses, primarily for neuromuscular stimulation or pain management therapies. They are intended for both clinical and home use, ensuring disposable application without the need for sterilization.
Where is Bio Medical Innovations based?
Bio Medical Innovations is headquartered in the United States. The company’s product development and manufacturing operations are conducted within the country, adhering to domestic regulatory standards for medical devices.
How are Bio Medical Innovations’ devices classified under FDA regulations?
Bio Medical Innovations’ TENS electrodes fall under FDA Class II medical devices. This classification is determined by the agency based on the device’s intended use, risk profile, and potential impact on patient safety. Class II devices require special controls beyond general controls to ensure their safety and effectiveness, such as performance standards or post-market surveillance.
Are Bio Medical Innovations’ devices listed in any regulatory registries?
Yes, Bio Medical Innovations’ devices are registered in the FDA’s Unique Device Identification (UDI) system. The UDI system assigns a unique product identifier to each device, enabling better tracking, traceability, and regulatory compliance. This helps healthcare providers, regulators, and manufacturers manage device information more effectively.
What is the primary purpose of the TENS electrodes manufactured by Bio Medical Innovations?
The primary purpose of Bio Medical Innovations’ single-use TENS electrodes is to deliver transcutaneous electrical stimulation for therapeutic applications. These electrodes are applied to the skin to stimulate nerves and muscles, which can help manage pain, reduce muscle spasms, or improve neuromuscular function. Their disposable design ensures hygiene and ease of use in both clinical and home settings.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- biomedical-innovations.com
- —
- —
- [email protected]
- Phone
- 2082635071
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 173358318
Catalogue (19)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Tpwt4-5 | TENS | FDA UDI | Class II | Active |
| Bf-6 | TENS | FDA UDI | Class II | Active |
| Ss-5 | TENS | FDA UDI | Class II | Active |
| Tpwt4-8 | TENS | FDA UDI | Class II | Active |
| Tpwt4-2 | TENS | FDA UDI | Class II | Active |
| Bf-4 | TENS | FDA UDI | Class II | Active |
| Bf-7 | TENS | FDA UDI | Class II | Active |
| Bf-5 | TENS | FDA UDI | Class II | Active |
| 200-11 | TENS | FDA UDI | Class II | Active |
| Bf-3 | TENS | FDA UDI | Class II | Active |
| Bf-2 | TENS | FDA UDI | Class II | Active |
| Tpwt4-4 | TENS | FDA UDI | Class II | Active |
| Tpwt4-6 | TENS | FDA UDI | Class II | Active |
| Tpwt4-7 | TENS | FDA UDI | Class II | Active |
| Ss-3 | TENS | FDA UDI | Class II | Active |
| Ss-6 | TENS | FDA UDI | Class II | Active |
| Ss-2 | TENS | FDA UDI | Class II | Active |
| Tpwt4-3 | TENS | FDA UDI | Class II | Active |
| Bf-8 | TENS | FDA UDI | Class II | Active |
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