Neurotech Medistim Plus, Type 291
FDA 510(k) K014019 · Bio-Medical Research, Ltd.
510(k) numberK014019
Submission
- Device name
- Neurotech Medistim Plus, Type 291
- Applicant
- Bio-Medical Research, Ltd.
Galway, IE - Received
- December 6, 2001
- Decision date
- July 11, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- IPF – Stimulator, Muscle, Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5850
- Specialty
- Physical Medicine
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Questions and answers
When was Neurotech Medistim Plus, Type 291 cleared by the FDA?
Neurotech Medistim Plus, Type 291 (K014019) received a 510(k) decision of Substantially Equivalent on July 11, 2002, 217 days after the submission was received.
What is the product code of K014019?
The FDA product code is IPF – Stimulator, Muscle, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.5850.