Q: Where is Shenzhen Kentro Medical Electronics Co., Ltd based, and how does this affect their devices?

Shenzhen Kentro Medical Electronics Co., Ltd operates from the United States, where their devices must comply with applicable medical device regulations. Since their products are electrical stimulation systems, they are subject to regulatory oversight in the US to ensure safety, performance, and proper labeling. The company’s location in the US also means their devices are listed in the FDA’s Unique Device Identifier (UDI) database, which helps track and identify these Class II devices.

Question 1

What types of medical devices does Shenzhen Kentro Medical Electronics Co., Ltd primarily manufacture?

Accepted Answer

Shenzhen Kentro Medical Electronics Co., Ltd specializes in transcutaneous electrical nerve stimulation (TENS) systems and neuromuscular electrical stimulation (NMES) devices. Their devices include TENS systems for pain relief and NMES systems for physical therapy, such as powered muscle stimulators and low-frequency therapy instruments. These systems deliver controlled electrical impulses to help manage pain or support muscle recovery.

Question 2

Where is Shenzhen Kentro Medical Electronics Co., Ltd based, and how does this affect their devices?

Accepted Answer

Shenzhen Kentro Medical Electronics Co., Ltd manufactures transcutaneous electrical nerve stimulation (TENS) systems designed for pain relief, as well as neuromuscular electrical stimulation (NMES) devices for physical therapy. Their portfolio includes powered muscle stimulators and low-frequency therapy instruments, which deliver targeted electrical impulses to manage pain or aid muscle recovery.

These devices fall under Class II regulatory classification in the US and are listed in the FDA’s Unique Device Identifier (UDI) database. The company operates from the United States, adhering to applicable medical device regulations for electrical stimulation therapies.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Question 3

Which regulatory registries list devices manufactured by Shenzhen Kentro Medical Electronics Co., Ltd?

Accepted Answer

Devices from Shenzhen Kentro Medical Electronics Co., Ltd are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is used to track and identify medical devices authorized for use in the US, ensuring transparency and traceability. The inclusion in this database reflects compliance with US regulatory requirements for Class II devices, which are generally considered moderate-risk medical products.

Question 4

How are the devices made by Shenzhen Kentro Medical Electronics Co., Ltd classified in the US?

Accepted Answer

The devices manufactured by Shenzhen Kentro Medical Electronics Co., Ltd fall under Class II regulatory classification in the US. This classification is assigned based on the risk level of the device—Class II devices typically require special controls in addition to general controls to ensure their safety and effectiveness. Since their products include TENS and NMES systems, they are subject to these controls to mitigate risks like improper electrical stimulation or misuse.

Device	Model / Reference	Registries	Class	Status
Powered Muscle Stimulator	KTR-234	FDA UDI	Class II	Active
Transcutaneous Electrical Nerve Stimulators	KTR-2220	FDA UDI	Class II	Active
Transcutaneous Electrical Nerve Stimulators	KTR-2341	FDA UDI	Class II	Active
Transcutaneous Electrical Nerve Stimulators	KTR-2230	FDA UDI	Class II	Active
Transcutaneous Electrical Nerve Stimulator For Pain Relief	KTR-2302	FDA UDI	Class II	Active
Low-Frequency Therapy Instrument	KTR-203	FDA UDI	Class II	Active
Transcutaneous Electrical Nerve Stimulator	KTR-4034	FDA UDI	Class II	Active
Transcutaneous Electrical Nerve Stimulators	KTR-2222	FDA UDI	Class II	Active
Transcutaneous Electrical Nerve Stimulators	KTR-2242	FDA UDI	Class II	Active
Powered Muscle Stimulator	KTR-230B	FDA UDI	Class II	Active
Transcutaneous Electrical Nerve Stimulators	KTR-2221	FDA UDI	Class II	Active
Transcutaneous Electrical Nerve Stimulator For Pain Relief	KTR-2401	FDA UDI	Class II	Active
Transcutaneous Electrical Nerve Stimulators	KTR-2252	FDA UDI	Class II	Active
Transcutaneous Electrical Nerve Stimulator	KTR-4026	FDA UDI	Class II	Active
Transcutaneous Electrical Nerve Stimulator	KTR-4032	FDA UDI	Class II	Active
Low-Frequency Therapy Instrument	KTR-202	FDA UDI	Class II	Active
Transcutaneous Electrical Nerve Stimulator	KTR-4036	FDA UDI	Class II	Active
Transcutaneous Electrical Nerve Stimulator For Pain Relief	KTR-2412	FDA UDI	Class II	Active
Transcutaneous Electrical Nerve Stimulator For Pain Relief	KTR-2411	FDA UDI	Class II	Active
Transcutaneous Electrical Nerve Stimulators	KTR-2611	FDA UDI	Class II	Active
Transcutaneous Electrical Nerve Stimulator	KTR-4039	FDA UDI	Class II	Active
Transcutaneous Electrical Nerve Stimulators	KTR-2652	FDA UDI	Class II	Active
Transcutaneous Electrical Nerve Stimulators	KTR-2250	FDA UDI	Class II	Active
Transcutaneous Electrical Nerve Stimulators	KTR-2342	FDA UDI	Class II	Active
Powered Muscle Stimulator	KTR-232	FDA UDI	Class II	Active
Transcutaneous Electrical Nerve Stimulators	KTR-2411	FDA UDI	Class II	Active
Transcutaneous Electrical Nerve Stimulator	KTR-4037	FDA UDI	Class II	Active
Transcutaneous Electrical Nerve Stimulators	KTR-2610	FDA UDI	Class II	Active
Transcutaneous Electrical Nerve Stimulators	KTR-2211	FDA UDI	Class II	Active
Transcutaneous Electrical Nerve Stimulators	KTR-2301	FDA UDI	Class II	Active
Transcutaneous Electrical Nerve Stimulators	KTR-2651	FDA UDI	Class II	Active
Transcutaneous Electrical Nerve Stimulators	KTR-2412	FDA UDI	Class II	Active
Transcutaneous Electrical Nerve Stimulator	KTR-4027	FDA UDI	Class II	Active
Transcutaneous Electrical Nerve Stimulator	KTR-4031	FDA UDI	Class II	Active
Transcutaneous Electrical Nerve Stimulators	KTR-2231	FDA UDI	Class II	Active
Transcutaneous Electrical Nerve Stimulators	KTR-2641	FDA UDI	Class II	Active
Transcutaneous Electrical Nerve Stimulators	KTR-2251	FDA UDI	Class II	Active
Low-Frequency Therapy Instrument	KTR-206	FDA UDI	Class II	Active
Transcutaneous Electrical Nerve Stimulators	KTR-2241	FDA UDI	Class II	Active
Low-Frequency Therapy Instrument	KTR-201	FDA UDI	Class II	Active
Transcutaneous Electrical Nerve Stimulators	KTR-2491	FDA UDI	Class II	Active
Transcutaneous Electrical Nerve Stimulators	KTR-2212	FDA UDI	Class II	Active
Powered Muscle Stimulator	KTR-233	FDA UDI	Class II	Active
Transcutaneous Electrical Nerve Stimulators	KTR-2210	FDA UDI	Class II	Active
Transcutaneous Electrical Nerve Stimulators	KTR-2612	FDA UDI	Class II	Active
Transcutaneous Electrical Nerve Stimulators	KTR-2402	FDA UDI	Class II	Active
Transcutaneous Electrical Nerve Stimulators	KTR-2240	FDA UDI	Class II	Active
Transcutaneous Electrical Nerve Stimulator	KTR-4021	FDA UDI	Class II	Active
Transcutaneous Electrical Nerve Stimulator	KTR-4012	FDA UDI	Class II	Active
Transcutaneous Electrical Nerve Stimulator	KTR-208	FDA UDI	Class II	Active

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