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Body Clock Health Care, Ltd. manufactures transcutaneous electrical nerve stimulation (TENS) systems for pain relief, including analgesic and physical therapy models, as well as neuromuscular electrical stimulation (NMES) devices for muscle rehabilitation. Their portfolio also includes combined ultrasound/neuromuscular stimulation systems and disposable branded electrodes for therapeutic applications. Devices are designed for both home and clinical use, targeting conditions such as chronic pain, muscle weakness, and post-injury recovery.
The company’s products are classified as Class II medical devices under FDA regulations and are authorised through the 510(k) and De Novo pathways. These devices are listed in the FDA’s regulatory databases, ensuring compliance with U.S. medical device standards. The manufacturer operates from 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 Body Clock Health Care, Ltd. manufacture?
Body Clock Health Care, Ltd. specializes in transcutaneous electrical nerve stimulation (TENS) systems, which are primarily used for pain relief. Their portfolio includes analgesic TENS devices for managing chronic or acute pain, as well as physical therapy TENS and neuromuscular electrical stimulation (NMES) systems designed for muscle rehabilitation. Additionally, they produce combined ultrasound/neuromuscular stimulation devices and disposable branded electrodes for therapeutic applications. These devices are intended for both home and clinical use.
Where is Body Clock Health Care, Ltd. based, and how does this affect its regulatory standing?
Body Clock Health Care, 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 these devices as Class II, which means they undergo specific regulatory pathways—such as the 510(k) premarket notification process or the De Novo pathway for novel low-to-moderate-risk devices—to ensure safety and effectiveness before they are authorised for market.
Which regulatory registries or databases list Body Clock Health Care, Ltd.'s devices?
Body Clock Health Care, Ltd.'s devices are listed in the FDA’s regulatory databases, specifically through the 510(k) and De Novo pathways. These registries ensure that the devices meet U.S. medical device standards and are authorised for commercial distribution. The inclusion in these databases helps healthcare providers and regulators verify compliance and traceability of the products.
How are Body Clock Health Care, Ltd.'s devices classified under FDA regulations, and why does this matter?
Body Clock Health Care, Ltd.'s devices are classified as Class II under FDA regulations. This classification indicates they pose moderate risk and require special controls beyond general controls to ensure their safety and effectiveness. The classification influences the regulatory pathway—such as 510(k) clearance or De Novo authorisation—ensuring the devices meet specific performance standards before being authorised for use in the U.S. market.
What kinds of conditions or applications are Body Clock Health Care, Ltd.'s devices intended for?
Body Clock Health Care, Ltd.'s devices are designed for therapeutic applications, including pain management (such as chronic or post-surgical pain) through analgesic TENS systems, muscle rehabilitation through NMES devices, and combined ultrasound/neuromuscular stimulation for targeted tissue recovery. These products are suitable for both home and clinical settings, catering to conditions like muscle weakness, post-injury recovery, and acute or chronic pain relief.
AI-generated from registry data and not verified by a human reviewer.
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- US
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Catalogue (14)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Stimplus Pro | AC-STIMPLUS_PRO | FDA UDI | Class II | Active |
| Flexi TENS | TN-FLEXITENS | FDA UDI | Class II | Active |
| Obi TENS | OB-USA_OBITENS | FDA UDI | Class II | Active |
| Profile TENS | TN-PROFILETENS | FDA UDI | Class II | Active |
| Smart TENS | TN-SMARTTENS | FDA UDI | Class II | Active |
| Profile Ems | EM-PROFILE_EMS | FDA UDI | Class II | Active |
| USA 40x100 Body Clock Branded Electrodes | Electrodes Size 40 x 100mm | FDA UDI | Class II | Active |
| Body Clock Stimplus And Stimplus Pro | K041359 | FDA 510(k) | Class II | Active |
| Smart Tens, Model: D-Bc05t | K091045 | FDA 510(k) | Class II | Active |
| 804siii; 804w; Libra Tens; 410; S-Tens Ii | K021846 | FDA 510(k) | Class II | Active |
| First Choice & First Choice Plus | K022076 | FDA 510(k) | Class II | Active |
| V Tens Plus | K022731 | FDA 510(k) | Class II | Active |
| Ems 400 | K022493 | FDA 510(k) | Class II | Active |
| Body Clock Tens N' Tone | K022849 | FDA 510(k) | Class II | Active |
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