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Sign in to claim this brandBio-Medical Research, Ltd.
US
Last updated May 23, 2026
What Bio-Medical Research, Ltd. makes
Bio-Medical Research, Ltd. manufactures single-use transcutaneous electrical stimulation electrodes, transcutaneous electrical stimulation leads, and physical therapy systems for neuromuscular electrical stimulation. Their portfolio includes arthritis TENS systems and toning devices designed for targeted muscle stimulation, such as abdominal, arm, and thigh toning pads. Examples include accessory packs, controller units, and replacement gel pads for specific models.
The company’s devices are classified as Class II under FDA regulations and are listed via 510(k) premarket notifications and the FDA’s Unique Device Identifier (UDI) system. Their products are 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 Bio-Medical Research, Ltd. manufacture?
Bio-Medical Research, Ltd. specializes in transcutaneous electrical stimulation (TENS) devices and related accessories. Their portfolio includes single-use TENS electrodes, transcutaneous electrical stimulation leads, and neuromuscular electrical stimulation (NMES) systems for physical therapy. They also produce arthritis TENS systems and toning devices, such as abdominal, arm, and thigh stimulation pads, designed to target specific muscle groups for therapeutic or cosmetic purposes.
Where is Bio-Medical Research, Ltd. based, and how does that affect their regulatory standing?
Bio-Medical Research, Ltd. is based in the United States, which means their devices fall under FDA jurisdiction. Since they manufacture Class II devices, these products require compliance with FDA regulations, including premarket notifications (510(k)) and Unique Device Identifier (UDI) requirements to ensure safety and performance standards are met.
Which regulatory registries or databases list Bio-Medical Research, Ltd.’s devices?
Bio-Medical Research, Ltd.’s devices are listed in the FDA’s 510(k) premarket notification database and the FDA’s Unique Device Identifier (UDI) system. These registries confirm that their products have undergone the necessary regulatory processes to demonstrate compliance with FDA requirements for Class II devices.
How are Bio-Medical Research, Ltd.’s devices classified under FDA regulations?
Bio-Medical Research, Ltd.’s devices are classified as Class II under FDA regulations. This classification applies to products that pose moderate risk and require special controls beyond general controls to ensure their safety and effectiveness. Examples include TENS systems and toning devices, which require validation of performance, labeling requirements, and post-market surveillance to maintain compliance.
AI-generated from registry data and not verified by a human reviewer.
Information
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- US
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Catalogue (62)
Page 2 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Bmr Powerstim | K840149 | FDA 510(k) | Class II | Active |
| Slendertone Enervive, Model 561 | K071666 | FDA 510(k) | Class II | Active |
| Innovo | DEN170049 | FDA 510(k) | Class II | Active |
| System-Mini, Models: 390, E30 | K072294 | FDA 510(k) | Class II | Active |
| SLENDERTONE® Connect Abs, Type 570 | K161974 | FDA 510(k) | Class II | Active |
| Slendertone Flex Abdominal Training System, Type 515 | K030708 | FDA 510(k) | Class II | Active |
| Kneehab Xp Controller, Model 411 | K092791 | FDA 510(k) | Class II | Active |
| Kneehab Xp | K110350 | FDA 510(k) | Class II | Active |
| Slendertone System Ultra Model E70/X70 | K100320 | FDA 510(k) | Class II | Active |
| Medistim Xp, Type 281 And Meditens Xp, Type 458 | K082011 | FDA 510(k) | Class II | Active |
| Slendertone Flex Max, Model 517 Us | K100556 | FDA 510(k) | Class II | Active |
| SLENDERTONE Evolve Abs, Type 735 | K203513 | FDA 510(k) | Class II | Active |
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