K212909 is an FDA 510(k) clearance for the VacuumCushions, FeetSupports, LEPS (Lower Extermities Positioning System), CouchStrips. This device is classified as a Accelerator, Linear, Medical (Class II - Special Controls, product code IYE).
Submitted by Macromedics BV (Moordrecht, NL). The FDA issued a Cleared decision on May 11, 2022, 240 days after receiving the submission on September 13, 2021.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5050.
| 510(k) Number | K212909 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 13, 2021 |
| Decision Date | May 11, 2022 |
| Days to Decision | 240 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | IYE - Accelerator, Linear, Medical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.5050 |