Stim2Go
FDA 510(k) K230701 · PAJUNK GmbH Medizintechnologie
510(k) numberK230701
Submission
- Device name
- Stim2Go
- Applicant
- PAJUNK GmbH Medizintechnologie
Geisingen, DE - Received
- March 14, 2023
- Decision date
- November 24, 2023
- 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 Stim2Go cleared by the FDA?
Stim2Go (K230701) received a 510(k) decision of Substantially Equivalent on November 24, 2023, 255 days after the submission was received.
What is the product code of K230701?
The FDA product code is IPF – Stimulator, Muscle, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.5850.