Reusable Stimulating Electrodes
FDA 510(k) K111270 · Bio Protech, Inc.
510(k) numberK111270
Submission
- Device name
- Reusable Stimulating Electrodes
- Applicant
- Bio Protech, Inc.
Dallas, TX, US - Received
- May 3, 2011
- Decision date
- September 13, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was Reusable Stimulating Electrodes cleared by the FDA?
Reusable Stimulating Electrodes (K111270) received a 510(k) decision of Substantially Equivalent on September 13, 2011, 133 days after the submission was received.
What is the product code of K111270?
The FDA product code is GXY – Electrode, Cutaneous, a Class II (moderate risk) device regulated under 21 CFR 882.1320.