P4 Physio
FDA 510(k) K022175 · Valmed Corp.
510(k) numberK022175
Submission
- Device name
- P4 Physio
- Applicant
- Valmed Corp.
Singer Island, FL, US - Received
- July 3, 2002
- Decision date
- September 9, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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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| K252816 | High Tone Power therapy (HiToP) (Model: HiToP PNP)IPF · Traditional | Mohammadali Nezakati | 06/02/2026SE |
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| 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 |
|---|---|---|
| K112148 | Powered Muscle StimulatorIPF · Traditional | 04/30/2012SE |
| K031611 | P4-FITNESSNGX · Traditional | 09/29/2004SE |
| 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 |
| K925336 | Valu-Plus PadKNN · Traditional | 02/12/1993SE |
Questions and answers
When was P4 Physio cleared by the FDA?
P4 Physio (K022175) received a 510(k) decision of Substantially Equivalent on September 9, 2002, 68 days after the submission was received.
What is the product code of K022175?
The FDA product code is IPF – Stimulator, Muscle, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.5850.