Electrostim I.F.
FDA 510(k) K873566 · Promatek Industries, Ltd.
510(k) numberK873566
Submission
- Device name
- Electrostim I.F.
- Applicant
- Promatek Industries, Ltd.
Quebec, H4p 2c9, CA - Received
- September 2, 1987
- Decision date
- February 1, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| K231575 | Vecttor VT-300LIH · Abbreviated | Artaflex, Inc. | 02/08/2024SE |
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| K183692 | Avid IF2LIH · Traditional | Vision Quest Industries Inc./Dba VQ Orthocare | 06/12/2019SE |
| K122944 | Gemore True Sine Interferential StimulatorLIH · Special | Gemore Technology Co, Ltd. | 12/21/2012SE |
| K121662 | Vecttor VT-200LIH · Abbreviated | Alan Neuromedical Technologies, LLC | 11/21/2012SE |
| 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 Electrostim I.F. cleared by the FDA?
Electrostim I.F. (K873566) received a 510(k) decision of Substantially Equivalent on February 1, 1988, 152 days after the submission was received.
What is the product code of K873566?
The FDA product code is LIH – Interferential Current Therapy, a Class II (moderate risk) device regulated under 21 CFR 882.5890.