MYOTouch Muscle Stimulator
FDA 510(k) K233098 · Sunmed, LLC
510(k) numberK233098
Submission
- Device name
- MYOTouch Muscle Stimulator
- Applicant
- Sunmed, LLC
Grand Rapids, MI, US - Received
- September 26, 2023
- Decision date
- August 2, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- IPF – Stimulator, Muscle, Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5850
- Specialty
- Physical Medicine
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| K240234 | BTL-899MSIPF · Traditional | BTL Industries, Inc. | 08/17/2024SE |
| K232786 | Stimulation System (PA series, PR series, S series and Q series)IPF · Traditional | Edan Instruments, Inc. | 05/16/2024SE |
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| K121743 | Easymed Peripheral Nerve Stimulator-SunstinBXN · Traditional | 03/28/2013SE |
| K081805 | CuffalertBSK · Traditional | 11/14/2008SE |
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| K955632 | Orthoplug Soft Bone DesignLZN · Traditional | 02/27/1996SE |
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Questions and answers
When was MYOTouch Muscle Stimulator cleared by the FDA?
MYOTouch Muscle Stimulator (K233098) received a 510(k) decision of Substantially Equivalent on August 2, 2024, 311 days after the submission was received.
What is the product code of K233098?
The FDA product code is IPF – Stimulator, Muscle, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.5850.