Low-Frequency Therapy Instrument /Model: KTR-201, KTR-202, KTR-203
FDA 510(k) K170205 · Shenzhen Kentro Medical Electronics Co., Ltd.
510(k) numberK170205
Submission
- Device name
- Low-Frequency Therapy Instrument /Model: KTR-201, KTR-202, KTR-203
- Applicant
- Shenzhen Kentro Medical Electronics Co., Ltd.
Shenzhen, CN - Received
- January 23, 2017
- Decision date
- May 11, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K252688 | Transcutaneous Electrical Nerve Stimulator (RJTENS-2)NUH · Traditional | Bozhou Rongjian Medical Appliance Co., Ltd. | 11/24/2025SE |
| K251856 | Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4NUH · Special | Everyway Medical Instruments Co.,Ltd | 11/21/2025SE |
| K243131 | Triathlon ProNUH · Traditional | Sigma Biomedical | 11/07/2025SE |
More from Sigma Biomedical
| 510(k) | Device | Decision |
|---|---|---|
| K242332 | Transcutaneous Electronic Nerve Stimulator (KTR-2301, KTR-2302, KTR-2341, KTR-2342…NUH · Traditional | 11/05/2024SE |
| K232517 | Transcutaneous Electrical Nerve Stimulator For Pain Relief (Model: KTR-2302, KTR-2401…NUH · Traditional | 12/08/2023SE |
| K222870 | Transcutaneous Electrical Nerve Stimulator, Model: KTR-4031, KTR-4032, KTR-4012…NUH · Traditional | 05/10/2023SE |
| K220998 | Transcutaneous Electrical Nerve Stimulator, Model: KTR-405NUH · Traditional | 08/24/2022SE |
| K200177 | Low-frequency Multi-function physiotherapy instrumentNUH · Traditional | 03/25/2021SE |
| K200237 | Transcutaneous Electronic Nerve StimulatorNUH · Traditional | 10/19/2020SE |
| K191982 | Low-Frequency Multi-function Physiotherapy Instrument (Model: KTR-2230, KTR-2220…NUH · Traditional | 09/25/2020SE |
| K183288 | Transcutaneous Electrical Nerve StimulatorNUH · Traditional | 07/30/2019SE |
| K181728 | Muscle TrainerNGX · Traditional | 10/17/2018SE |
Questions and answers
When was Low-Frequency Therapy Instrument /Model: KTR-201, KTR-202, KTR-203 cleared by the FDA?
Low-Frequency Therapy Instrument /Model: KTR-201, KTR-202, KTR-203 (K170205) received a 510(k) decision of Substantially Equivalent on May 11, 2017, 108 days after the submission was received.
What is the product code of K170205?
The FDA product code is NUH – Stimulator, Nerve, Transcutaneous, Over-The-Counter, a Class II (moderate risk) device regulated under 21 CFR 882.5890.