Neurodyn Multiwave, Aussie Sport
FDA 510(k) K131629 · Ibramed Equipamentos Medicos
510(k) numberK131629
Submission
- Device name
- Neurodyn Multiwave, Aussie Sport
- Applicant
- Ibramed Equipamentos Medicos
Aventura, FL, US - Received
- June 4, 2013
- Decision date
- November 26, 2013
- 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
Other 510(k)s with product code IPF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
|---|---|---|
| K210572 | Neurodyn V2.0, Neurodyn Aussie V2.0IPF · Traditional | 05/11/2021SE |
| K131926 | ThermopulseIMJ · Traditional | 07/24/2014SE |
| K131917 | Neurodyn Compact, Neurodyn IIIPF · Traditional | 04/29/2014SE |
| K131309 | Sonopulse Compact 1MHZ, Sonopulse Compact 3MHZIMI · Traditional | 01/27/2014SE |
| K121369 | Neurodyn Ruby Muscle Stimulator, Neurodyn Aussie Muscle StimulatorGZJ · Traditional | 12/19/2012SE |
Questions and answers
When was Neurodyn Multiwave, Aussie Sport cleared by the FDA?
Neurodyn Multiwave, Aussie Sport (K131629) received a 510(k) decision of Substantially Equivalent on November 26, 2013, 175 days after the submission was received.
What is the product code of K131629?
The FDA product code is IPF – Stimulator, Muscle, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.5850.