FDA 510(k)

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

Número K: K212909 · 2022-05-11

Data da decisão2022-05-11

Código do produtoIYE

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

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

Perguntas frequentes

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. The listed applicant is Macromedics BV. The 510(k) number is K212909.

When did VacuumCushions, FeetSupports, LEPS (Lower Extermities Positioning System), CouchStrips receive FDA 510(k) clearance?

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

Who is the listed applicant for VacuumCushions, FeetSupports, LEPS (Lower Extermities Positioning System), CouchStrips?

The FDA 510(k) record lists Macromedics BV as the applicant. This does not by itself establish the device manufacturer.

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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Outros registros que listam Macromedics BV como candidato(a)

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 K222977DSPS-Prominent™ Masks; DSPS-Prominent™ Baseplate, MR; CouchStrip K213439FlexBoardTM, EagleBoardTM, BreastBoard SXTM

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