Avivafix Conductive Garment-Knee/Shoulder/Upper Back, Type 40
FDA 510(k) K102614 · Bio-Medical Research, Ltd.
510(k) numberK102614
Submission
- Device name
- Avivafix Conductive Garment-Knee/Shoulder/Upper Back, Type 40
- Applicant
- Bio-Medical Research, Ltd.
Galway, IE - Received
- September 10, 2010
- Decision date
- June 3, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Avivafix Conductive Garment-Knee/Shoulder/Upper Back, Type 40 cleared by the FDA?
Avivafix Conductive Garment-Knee/Shoulder/Upper Back, Type 40 (K102614) received a 510(k) decision of Substantially Equivalent on June 3, 2011, 266 days after the submission was received.
What is the product code of K102614?
The FDA product code is GXY – Electrode, Cutaneous, a Class II (moderate risk) device regulated under 21 CFR 882.1320.