VacuumCushions, FeetSupports, LEPS (Lower Extermities Positioning System), CouchStrips
FDA 510(k) K212909 · Macromedics BV
510(k) numberK212909
Submission
- Device name
- VacuumCushions, FeetSupports, LEPS (Lower Extermities Positioning System), CouchStrips
- Applicant
- Macromedics BV
Moordrecht, NL - Received
- September 13, 2021
- Decision date
- May 11, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was VacuumCushions, FeetSupports, LEPS (Lower Extermities Positioning System), CouchStrips cleared by the FDA?
VacuumCushions, FeetSupports, LEPS (Lower Extermities Positioning System), CouchStrips (K212909) received a 510(k) decision of Substantially Equivalent on May 11, 2022, 240 days after the submission was received.
What is the product code of K212909?
The FDA product code is IYE – Accelerator, Linear, Medical, a Class II (moderate risk) device regulated under 21 CFR 892.5050.