Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4
FDA 510(k) K251856 · Everyway Medical Instruments Co.,Ltd
510(k) numberK251856
Submission
- Device name
- Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4
- Applicant
- Everyway Medical Instruments Co.,Ltd
New Taipei City, TW - Received
- June 17, 2025
- Decision date
- November 21, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code NUH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261131 | Electrical Muscle Stimulator (AST-105DJ, AST-105EJ, AST- 105BJ, AST-105GJ, AST-303J…NUH · Traditional | Shenzhen Osto Medical Technology Co.,Ltd | 09/06/2026SE |
| K260412 | TENS 7000 Rechargeable 4 Channel (TENS 7000H)NUH · Traditional | Shenzhen Dongdixin Technology Co., Ltd. | 06/26/2026SE |
| K260425 | TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237)NUH · Traditional | Hivox Biotek, Inc. | 06/16/2026SE |
| K253896 | TENS/EMS device (GUSE01)NUH · Traditional | Globalcare Medical Technology Co., Ltd. | 03/04/2026SE |
| K253305 | TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034)NUH · Traditional | Shenzhen Jiantuo Electronics Co., Ltd. | 12/31/2025SE |
| K253740 | Tens&Ems (HZ9151B, HZ9151C, HZ9151D)NUH · Traditional | Hong Qiangxing (Shenzhen) Electronics Limited | 12/23/2025SE |
| K251958 | VEINOPLUS BackNUH · Traditional | Dynapulse Medical | 12/23/2025SE |
| K252688 | Transcutaneous Electrical Nerve Stimulator (RJTENS-2)NUH · Traditional | Bozhou Rongjian Medical Appliance Co., Ltd. | 11/24/2025SE |
| K243131 | Triathlon ProNUH · Traditional | Sigma Biomedical | 11/07/2025SE |
| K251429 | OTC 4-Channel Rechargeable TENS UnitNUH · Special | Changsha Anxiang Medical Technology Co., Ltd. | 08/28/2025SE |
More from Changsha Anxiang Medical Technology Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K222488 | Everyway Analog OTC TENSNUH · Traditional | 11/15/2022SE |
| K213116 | Everyway Incontinence Stimulation SystemKPI · Traditional | 12/03/2021SE |
| K202849 | Everyway Analog OTC TENS, model N103A/N302NUH · Traditional | 12/22/2020SE |
| K202470 | Li-Battery powered OTC TENS/EMS, model EM-6000, EM-6100, EM-6200 & EM-6300NUH · Traditional | 11/25/2020SE |
| K202317 | Li-Battery powered OTC TENS/EMS, model EV-804, model EV-805, & model EV-806NUH · Traditional | 11/13/2020SE |
| K201335 | Li-Battery powered OTC TENS/EMS Combination StimulatorNUH · Traditional | 10/24/2020SE |
| K192589 | Everyway OTC TENS/EMS CombinationNUH · Traditional | 12/19/2019SE |
| K182767 | V2 OTC Pain Relief TENSNUH · Special | 10/26/2018SE |
| K182753 | A6 OTC Pain Relief TENSNUH · Special | 10/26/2018SE |
| K181707 | Everyway Wireless TENS & EMS UnitNUH · Traditional | 09/26/2018SE |
Questions and answers
When was Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4 cleared by the FDA?
Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4 (K251856) received a 510(k) decision of Substantially Equivalent on November 21, 2025, 157 days after the submission was received.
What is the product code of K251856?
The FDA product code is NUH – Stimulator, Nerve, Transcutaneous, Over-The-Counter, a Class II (moderate risk) device regulated under 21 CFR 882.5890.