TENS & PMS
FDA 510(k) K201354 · Hong Qiangxing (Shenzhen) Electronics Limited
Submission
- Device name
- TENS & PMS
- Applicant
- Hong Qiangxing (Shenzhen) Electronics Limited
Shenzhen, CN - Received
- May 21, 2020
- Decision date
- December 11, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NGX – Stimulator, Muscle, Powered, For Muscle Conditioning
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5850
- Specialty
- Physical Medicine
A powered muscle stimulator for muscle conditioning is a device used for other than medical purposes to apply an electrical current to electrodes on a person's skin to temporarily affect the stimulated muscle's contractile properties, force output, and/or fatigue resistance. Unlike the classified Powered Muscle Stimulator devices intended for use in physical medicine and rehabilitation, this…
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| K253790 | High Intensity Focused Electromagnetic Stimulation Device (FE60)NGX · Traditional | Beijing Winkonlaser Technology Limited | 08/13/2026SE |
| K253926 | DiacoreNGX · Traditional | ShenB Co., Ltd. | 04/10/2026SE |
| K253636 | Zionic Pro Max (EMS)NGX · Traditional | Termosalud S.L. | 03/12/2026SE |
| K253408 | CoolToneNGX · Traditional | Zimmer Medizinsysteme GmbH | 01/16/2026SE |
| K252154 | Portable Electro Stimulation Therapy Device (LGT-2320BE, LGT-2320ME, and LGT-2320SP)NGX · Traditional | Guangzhou Longest Medical Technology Co., Ltd. | 12/09/2025SE |
| K253478 | Motive Muscle Stimulator for Lower Back (OT01-1003)NGX · Traditional | Motive Health, Inc. | 11/06/2025SE |
| K251594 | truFlexNGX · Special | Syrma Johari Medtech Limited | 08/28/2025SE |
| K251706 | TENS and EMS UnitNGX · Special | Changsha Anxiang Medical Technology Co., Ltd. | 07/30/2025SE |
| K251378 | CoolToneNGX · Special | Zimmer Medizinsysteme GmbH | 07/14/2025SE |
| K251746 | Pure ImpactNGX · Special | Sofwave Medical, Ltd. | 07/02/2025SE |
More from Sofwave Medical, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K253740 | Tens&Ems (HZ9151B, HZ9151C, HZ9151D)NUH · Traditional | 12/23/2025SE |
| K220283 | TENS & PMS (Model:SM9009, SM9021, SM9128H, SM9015, SM9055, SM9033)NUH · Traditional | 05/02/2022SE |
| K220152 | TENS & PMS (Model:SM9089, SM9587, SM9592, SM9555)NUH · Traditional | 04/19/2022SE |
| K220150 | TENS & PMS (Model: SM9126)NUH · Traditional | 02/17/2022SE |
| K190009 | Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S)NUH · Traditional | 12/02/2019SE |
| K183154 | SM ElectrodesGXY · Traditional | 03/26/2019SE |
| K133108 | Fit BeltNGX · Traditional | 08/05/2014SE |
| K121719 | SM TENS & PMSNGX · Traditional | 05/10/2013SE |
Questions and answers
When was TENS & PMS cleared by the FDA?
TENS & PMS (K201354) received a 510(k) decision of Substantially Equivalent on December 11, 2020, 204 days after the submission was received.
What is the product code of K201354?
The FDA product code is NGX – Stimulator, Muscle, Powered, For Muscle Conditioning, a Class II (moderate risk) device regulated under 21 CFR 890.5850.