Electronic Muscle Stimulator (Model: AST-300A, AST-300N, AST-300S, AST-300T, AST-300V, AST-300W)
FDA 510(k) K211736 · Shenzhen Osto Technology Company Limited
510(k) numberK211736
Submission
- Device name
- Electronic Muscle Stimulator (Model: AST-300A, AST-300N, AST-300S, AST-300T, AST-300V, AST-300W)
- Applicant
- Shenzhen Osto Technology Company Limited
Shenzhen, CN - Received
- June 7, 2021
- Decision date
- September 5, 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 |
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| 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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| K212989 | Low-frequency Stimulator (Model: AST-645, AST-646)NUH · Traditional | 11/22/2021SE |
| K210756 | Neck Care Therapy, Model: AST-905A, AST-905D, AST-905HNUH · Traditional | 06/11/2021SE |
| K190783 | Health Expert Electronic Stimulator (model: AST-300L)NUH · Traditional | 03/14/2020SE |
| K190673 | Health Expert Electronic StimulatorNUH · Traditional | 12/12/2019SE |
| K182136 | Intelligent Wireless Fitness Apparatus (Model: AST-301, AST-302, AST-303)NUH · Traditional | 10/10/2019SE |
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Questions and answers
When was Electronic Muscle Stimulator (Model: AST-300A, AST-300N, AST-300S, AST-300T, AST-300V, AST-300W) cleared by the FDA?
Electronic Muscle Stimulator (Model: AST-300A, AST-300N, AST-300S, AST-300T, AST-300V, AST-300W) (K211736) received a 510(k) decision of Substantially Equivalent on September 5, 2021, 90 days after the submission was received.
What is the product code of K211736?
The FDA product code is NUH – Stimulator, Nerve, Transcutaneous, Over-The-Counter, a Class II (moderate risk) device regulated under 21 CFR 882.5890.