The following data is part of a premarket notification filed by Macromedics Bv with the FDA for Leps, Leps Feetsupport (including Variations Of Feetsupport, Kneesupport, Kneesupport Liftblock, Shoulder Retr. For Leps, Leps Baseplate, Leps Baseplate Short), Feetsupport (various Models) ,couchstrip, Vacuumcushion Pos. Strip, Mridian Rail (various.
| Device ID | K212909 |
| 510k Number | K212909 |
| Device Name: | LEPS, LEPS FeetSupport (including Variations Of FeetSupport, KneeSupport, KneeSupport LiftBlock, Shoulder Retr. For LEPS, LEPS Baseplate, LEPS Baseplate Short), FeetSupport (various Models) ,CouchStrip, VacuumCushion Pos. Strip, MRIdian Rail (various |
| Classification | Accelerator, Linear, Medical |
| Applicant | MacroMedics BV Oostbaan 670 Moordrecht, NL 2841 ML |
| Contact | Elizabeth Hajos |
| Correspondent | Elizabeth Hajos MacroMedics BV Oostbaan 670 Moordrecht, NL 2841 ML |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-13 |
| Decision Date | 2022-05-11 |