Muscle and Nerve Stimulator TENS & EMS (TP2208), Muscle and Nerve Stimulator TENS & EMS (TP2208C)
FDA 510(k) K242567 · Changsha Anxiang Medical Technology Co., Ltd.
510(k) numberK242567
Submission
- Device name
- Muscle and Nerve Stimulator TENS & EMS (TP2208), Muscle and Nerve Stimulator TENS & EMS (TP2208C)
- Applicant
- Changsha Anxiang Medical Technology Co., Ltd.
Changsha, CN - Received
- August 29, 2024
- Decision date
- November 4, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
|---|---|---|
| K251429 | OTC 4-Channel Rechargeable TENS UnitNUH · Special | 08/28/2025SE |
| K251706 | TENS and EMS UnitNGX · Special | 07/30/2025SE |
| K251187 | 3 in 1 TENS UNIT (TC1241, TC2241, TS1241)NUH · Traditional | 07/28/2025SE |
| K250759 | 3 in 1 TENS UNITNGX · Traditional | 06/13/2025SE |
| K243763 | Wireless TENS & EMS UnitNGX · Traditional | 03/12/2025SE |
| K243511 | OTC TENS & EMS UnitNGX · Traditional | 02/10/2025SE |
| K242787 | Tens & Ems Device (TU1080)NGX · Traditional | 12/18/2024SE |
Questions and answers
When was Muscle and Nerve Stimulator TENS & EMS (TP2208), Muscle and Nerve Stimulator TENS & EMS (TP2208C) cleared by the FDA?
Muscle and Nerve Stimulator TENS & EMS (TP2208), Muscle and Nerve Stimulator TENS & EMS (TP2208C) (K242567) received a 510(k) decision of Substantially Equivalent on November 4, 2024, 67 days after the submission was received.
What is the product code of K242567?
The FDA product code is NUH – Stimulator, Nerve, Transcutaneous, Over-The-Counter, a Class II (moderate risk) device regulated under 21 CFR 882.5890.