Heat StimPlus
FDA 510(k) K212918 · Famidoc Technology Co., Ltd.
510(k) numberK212918
Submission
- Device name
- Heat StimPlus
- Applicant
- Famidoc Technology Co., Ltd.
Dongguan, CN - Received
- September 14, 2021
- Decision date
- December 13, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
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| K233192 | Wireless Smart ThermometerFLL · Traditional | 04/05/2024SE |
| K222887 | Arm Blood Pressure Monitor/Automatic Wireless Smart Blood Pressure MonitorDXN · Traditional | 04/10/2023SE |
| K191673 | Upper Arm Blood Pressure MonitorDXN · Traditional | 11/27/2019SE |
| K130723 | FDES106 Mini Tens&Ems DEVICE,FDES106 Multi-Function Mini Tens&Ems DEVICE,FDES105 Pain…NGX · Traditional | 02/07/2014SE |
| K113010 | FDES100(TENS and EMS Stimulator, FDES102(ED402) TENS StimulatorIPF · Traditional | 12/21/2012SE |
| K113761 | Infrared ThermometerFLL · Traditional | 09/07/2012SE |
| K072641 | Digital Electronic Thermometer, Model: FDTH-V0-1 Thru 4.FLL · Traditional | 11/01/2007SE |
| K052849 | Infrared Thermometer, FDIR-V1FLL · Traditional | 10/26/2005SE |
Questions and answers
When was Heat StimPlus cleared by the FDA?
Heat StimPlus (K212918) received a 510(k) decision of Substantially Equivalent on December 13, 2021, 90 days after the submission was received.
What is the product code of K212918?
The FDA product code is NUH – Stimulator, Nerve, Transcutaneous, Over-The-Counter, a Class II (moderate risk) device regulated under 21 CFR 882.5890.