Powered Muscle Stimulator
FDA 510(k) K112148 · Valmed, SA
510(k) numberK112148
Submission
- Device name
- Powered Muscle Stimulator
- Applicant
- Valmed, SA
Sion, Valais, CH - Received
- July 27, 2011
- Decision date
- April 30, 2012
- 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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| K252816 | High Tone Power therapy (HiToP) (Model: HiToP PNP)IPF · Traditional | Mohammadali Nezakati | 06/02/2026SE |
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| 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 |
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| K010754 | Nurse's Assistant O.R. Control SystemGCJ · Traditional | 08/15/2001SE |
| K010716 | Val Lux 600 Surgical Light (Plus and RS), Model ML600/S: Single Light Head, ML600/SS:…FSY · Traditional | 05/30/2001SE |
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Questions and answers
When was Powered Muscle Stimulator cleared by the FDA?
Powered Muscle Stimulator (K112148) received a 510(k) decision of Substantially Equivalent on April 30, 2012, 278 days after the submission was received.
What is the product code of K112148?
The FDA product code is IPF – Stimulator, Muscle, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.5850.