Smartwave If 2000
FDA 510(k) K003631 · Newwave Medical, LLC
510(k) numberK003631
Submission
- Device name
- Smartwave If 2000
- Applicant
- Newwave Medical, LLC
Plano, TX, US - Received
- November 24, 2000
- Decision date
- August 10, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K122944 | Gemore True Sine Interferential StimulatorLIH · Special | Gemore Technology Co, Ltd. | 12/21/2012SE |
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| K110509 | Everyway Interferntial Stimulator, Model IF-908LIH · Traditional | Everyway Medical Instruments Co.,Ltd | 06/20/2011SE |
| K100246 | MAX-IF1000LIH · Traditional | Bio Protech, Inc. | 11/24/2010SE |
| K092780 | Inf 4160 Plus, Model D-FJ31FLIH · Traditional | Fuji Dynamics Limited | 01/07/2010SE |
| K092763 | If True Sine Interferential Stimulator, WL-2206DLIH · Special | Well-Life Healthcare Limited | 10/08/2009SE |
| K090023 | If Series True Sine Interferential Stimulator, Model: WL-2206B and WL-2106ELIH · Special | Well-Life Healthcare Limited | 01/30/2009SE |
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Questions and answers
When was Smartwave If 2000 cleared by the FDA?
Smartwave If 2000 (K003631) received a 510(k) decision of Substantially Equivalent on August 10, 2001, 259 days after the submission was received.
What is the product code of K003631?
The FDA product code is LIH – Interferential Current Therapy, a Class II (moderate risk) device regulated under 21 CFR 882.5890.