FDA 510(k)

VacuumCushions, FeetSupports, LEPS (Lower Extermities Positioning System), CouchStrips

K-Number: K212909 · 2022-05-11

Decision Date2022-05-11

Product CodeIYE

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

VacuumCushions, FeetSupports, LEPS (Lower Extermities Positioning System), CouchStrips is a medical device manufactured by Macromedics BV. It received FDA 510(k) clearance on 2022-05-11 under approval number K212909. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VacuumCushions, FeetSupports, LEPS (Lower Extermities Positioning System), CouchStrips?

VacuumCushions, FeetSupports, LEPS (Lower Extermities Positioning System), CouchStrips is a medical device that received FDA 510(k) clearance on 2022-05-11. It is manufactured by Macromedics BV. The 510(k) number is K212909.

When was VacuumCushions, FeetSupports, LEPS (Lower Extermities Positioning System), CouchStrips approved by the FDA?

VacuumCushions, FeetSupports, LEPS (Lower Extermities Positioning System), CouchStrips received FDA 510(k) clearance on 2022-05-11, under approval number K212909.

What company makes VacuumCushions, FeetSupports, LEPS (Lower Extermities Positioning System), CouchStrips?

VacuumCushions, FeetSupports, LEPS (Lower Extermities Positioning System), CouchStrips is manufactured by Macromedics BV.

What is the FDA product code for VacuumCushions, FeetSupports, LEPS (Lower Extermities Positioning System), CouchStrips?

The FDA product code for VacuumCushions, FeetSupports, LEPS (Lower Extermities Positioning System), CouchStrips is IYE.

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Other Devices by Macromedics BV

K213439FlexBoardTM, EagleBoardTM, BreastBoard SXTM K222977DSPS-Prominent Masks; DSPS-Prominent Baseplate, MR; CouchStrip K250429DSPS-Prominent® baseplate, MR (113820); DSPS-Prominent® baseplate (113120); DSPS-Prominent® Cradle-I (113140); DSPS-Prominent® Cradle-II (113150); DSPS-Prominent® Cradle-III (113160); DSPS-Prominent® Cradle-IV (113170); DSPS-Prominent® Cradle-VI (113180); DSPS-Prominent® Cradle-VII (113260); Mask DSPS®-PROSCVRL set/5 (113760); Mask DSPS®-PROSC set/5 (113770); Mask DSPS®-PROSCVR set/5 (113780); Mask DSPS®-PROSCL set/5 (113790); Mask DSPS®-PROSHVRL set/5 (113890); Mask DSPS®-PROSH set

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.