Interferential Stimulator, Model BMLS02-6
FDA 510(k) K040007 · Biomedical Life Systems, Inc.
510(k) numberK040007
Submission
- Device name
- Interferential Stimulator, Model BMLS02-6
- Applicant
- Biomedical Life Systems, Inc.
Vista, CA, US - Received
- January 2, 2004
- Decision date
- July 7, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was Interferential Stimulator, Model BMLS02-6 cleared by the FDA?
Interferential Stimulator, Model BMLS02-6 (K040007) received a 510(k) decision of Substantially Equivalent on July 7, 2004, 187 days after the submission was received.
What is the product code of K040007?
The FDA product code is LIH – Interferential Current Therapy, a Class II (moderate risk) device regulated under 21 CFR 882.5890.