Combo Electrotherapy Device
FDA 510(k) K231440 · Shenzhen Roundwhale Technology Co. , Ltd.
510(k) numberK231440
Submission
- Device name
- Combo Electrotherapy Device
- Applicant
- Shenzhen Roundwhale Technology Co. , Ltd.
Shenzhen, CN - Received
- May 18, 2023
- Decision date
- November 3, 2023
- 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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|---|---|---|---|
| K253542 | Apollo Quattro (APQ-10M)IPF · Traditional | Weero Co., Ltd. | 06/08/2026SE |
| K252816 | High Tone Power therapy (HiToP) (Model: HiToP PNP)IPF · Traditional | Mohammadali Nezakati | 06/02/2026SE |
| K260142 | StimelMD (SSMD) systemIPF · Special | Motion Informatics ltd. | 05/27/2026SE |
| K251083 | Compact IIIPF · Traditional | Enraf-Nonius, B.V. | 09/12/2025SE |
| K241433 | EVE Synergy (EVE-20M)IPF · Traditional | Weero Co., Ltd. | 06/04/2025SE |
| K241488 | TrainFES AdvanceIPF · Traditional | Trainfes | 02/05/2025SE |
| K240348 | Quantum Mitohormesis (QMT) (M2101)IPF · Abbreviated | Quantumtx Pte. , Ltd. | 12/19/2024SE |
| 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 |
|---|---|---|
| K231423 | Combo Electrotherapy Device (Models: R-C101C, R-C101D, R-C101F, R-C101G, F100…NUH · Traditional | 01/22/2024SE |
| K232995 | Neurological Therapy Devices - Accessories: Electrotherapy device Electrode belt for…GXY · Traditional | 01/11/2024SE |
| K222252 | Self-adhesive ElectrodeGXY · Traditional | 01/19/2023SE |
| K192087 | Combo Electrotherapy DeviceNUH · Traditional | 11/01/2019SE |
| K181688 | R-C1 TENS and EMS Stimulator; R-E1- EMS Stimulator; R-T1 TENS StimulatorIPF · Traditional | 09/07/2018SE |
| K180956 | Electrical Stimulator - Model R-C1 TENS and EMS stimulator, Model R-E1 EMS stimulator…NUH · Traditional | 06/07/2018SE |
Questions and answers
When was Combo Electrotherapy Device cleared by the FDA?
Combo Electrotherapy Device (K231440) received a 510(k) decision of Substantially Equivalent on November 3, 2023, 169 days after the submission was received.
What is the product code of K231440?
The FDA product code is IPF – Stimulator, Muscle, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.5850.