OTC Patch
FDA 510(k) K133723 · Well-Life Healthcare Limited
510(k) numberK133723
Submission
- Device name
- OTC Patch
- Applicant
- Well-Life Healthcare Limited
Yunghe City, Taipei County, TW - Received
- December 6, 2013
- Decision date
- January 28, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 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 |
| 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 |
|---|---|---|
| K251760 | Well-Life Incontinence Stimulation System (WL-2405i(P))KPI · Traditional | 02/12/2026SE |
| K233054 | Well-Life Pain Relief (Menstrual Plus) Electrical Stimulator; TENS/EMS WITH Menstrual…NUH · Traditional | 10/18/2024SE |
| K222528 | Well-Life Probe Electrode for Stimulation/EMG Probe (Model: SA), Well-Life Incontinence…KPI · Traditional | 12/29/2022SE |
| K220524 | Well-Life Mini TENS Stimulator(WL-23XXC/WL-23XXE Series)NUH · Traditional | 08/04/2022SE |
| K213091 | Well-Life TENS/EMS/Heating StimulatorNUH · Traditional | 02/19/2022SE |
| K200942 | Well-Life Garment Electrodes (GM Series)GXY · Traditional | 06/01/2021SE |
| K172809 | OTC Combo TENS/EMS SystemNUH · Special | 10/18/2017SE |
| K162663 | WELL LIFE Rx Wireless TENS/EMS Stimulator, model WR-2603/2603A, WR-2604/2604A and…GZJ · Traditional | 01/17/2017SE |
| K161453 | WELL LIFE Wireless TENS/EMS Stimulator, Models WR-2605/2605ANUH · Traditional | 12/05/2016SE |
| K141299 | OTC Combo Tens/Ems SystemNUH · Traditional | 11/14/2014SE |
Questions and answers
When was OTC Patch cleared by the FDA?
OTC Patch (K133723) received a 510(k) decision of Substantially Equivalent on January 28, 2014, 53 days after the submission was received.
What is the product code of K133723?
The FDA product code is NUH – Stimulator, Nerve, Transcutaneous, Over-The-Counter, a Class II (moderate risk) device regulated under 21 CFR 882.5890.