Prizm Medical, Inc. Micro-Z Stimulation System
FDA 510(k) K024181 · Prizm Medical, Inc.
510(k) numberK024181
Submission
- Device name
- Prizm Medical, Inc. Micro-Z Stimulation System
- Applicant
- Prizm Medical, Inc.
Dunwoody, GA, US - Received
- December 19, 2002
- Decision date
- June 26, 2003
- 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 Prizm Medical, Inc. Micro-Z Stimulation System cleared by the FDA?
Prizm Medical, Inc. Micro-Z Stimulation System (K024181) received a 510(k) decision of Substantially Equivalent on June 26, 2003, 189 days after the submission was received.
What is the product code of K024181?
The FDA product code is IPF – Stimulator, Muscle, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.5850.