PowerDot PD-01MT2 Muscle Stimulator
FDA 510(k) K210938 · Smartmissimo Technologies Pte, Ltd.
510(k) numberK210938
Submission
- Device name
- PowerDot PD-01MT2 Muscle Stimulator
- Applicant
- Smartmissimo Technologies Pte, Ltd.
Singapore, SG - Received
- March 29, 2021
- Decision date
- July 30, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) statement 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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| K240992 | eMVFit (MVF-10M)IPF · Traditional | Weero Co., Ltd. | 10/10/2024SE |
| K240234 | BTL-899MSIPF · Traditional | BTL Industries, Inc. | 08/17/2024SE |
| K233098 | MYOTouch Muscle StimulatorIPF · Traditional | Sunmed, LLC | 08/02/2024SE |
More from Sunmed, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K210269 | PowerDot PD-01MT2 Muscle StimulatorIPF · Special | 02/23/2021SE |
| K181759 | PowerDot PD-01MTIPF · Abbreviated | 11/09/2018SE |
| K172876 | PowerDot PD-01MNGX · Special | 12/04/2017SE |
| K150078 | PowerDot(R) PD-01 Muscle Stimulator (with PowerDot(R) Mobile Application)NGX · Traditional | 09/30/2015SE |
Questions and answers
When was PowerDot PD-01MT2 Muscle Stimulator cleared by the FDA?
PowerDot PD-01MT2 Muscle Stimulator (K210938) received a 510(k) decision of Substantially Equivalent on July 30, 2021, 123 days after the submission was received.
What is the product code of K210938?
The FDA product code is IPF – Stimulator, Muscle, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.5850.