Guardian Dysphagia Dual Channel Nmes Unit
FDA 510(k) K120922 · Selectivemed Components, Inc.
510(k) numberK120922
Submission
- Device name
- Guardian Dysphagia Dual Channel Nmes Unit
- Applicant
- Selectivemed Components, Inc.
Naples, FL, US - Received
- March 27, 2012
- Decision date
- February 7, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 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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| 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 |
|---|---|---|
| K083756 | Guardian 150 ElectrodeGXY · Traditional | 06/26/2009SE |
| K031053 | Selective Med Components, Inc. Buffered Iontophoresis Drug Delivery System Electrodes…EGJ · Traditional | 05/20/2003SE |
| K020476 | Medion 6000EGJ · Traditional | 05/03/2002SE |
| K993081 | Io-DriveEGJ · Traditional | 03/03/2000SE |
| K946230 | Endura Reusable TENS and Nmes ElectrodesGZJ · Traditional | 12/22/1995SE |
| K945676 | Guardian Disposable TENS and Tens/Nmes ElectrodesGZJ · Traditional | 01/30/1995SE |
Questions and answers
When was Guardian Dysphagia Dual Channel Nmes Unit cleared by the FDA?
Guardian Dysphagia Dual Channel Nmes Unit (K120922) received a 510(k) decision of Substantially Equivalent on February 7, 2013, 317 days after the submission was received.
What is the product code of K120922?
The FDA product code is IPF – Stimulator, Muscle, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.5850.