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FDA 510(k)

medi pneumatic compression system (pcs)-genius (Model 652)

K-Number: K221654 · 2022-07-07

ApplicantMedi USA, LP
Decision Date2022-07-07
Product CodeJOW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

medi pneumatic compression system (pcs)-genius (Model 652) is a medical device manufactured by Medi USA, LP. It received FDA 510(k) clearance on 2022-07-07 under approval number K221654. The device is classified under product code JOW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the medi pneumatic compression system (pcs)-genius (Model 652)?

medi pneumatic compression system (pcs)-genius (Model 652) is a medical device that received FDA 510(k) clearance on 2022-07-07. It is manufactured by Medi USA, LP. The 510(k) number is K221654.

When was medi pneumatic compression system (pcs)-genius (Model 652) approved by the FDA?

medi pneumatic compression system (pcs)-genius (Model 652) received FDA 510(k) clearance on 2022-07-07, under approval number K221654.

What company makes medi pneumatic compression system (pcs)-genius (Model 652)?

medi pneumatic compression system (pcs)-genius (Model 652) is manufactured by Medi USA, LP.

What is the FDA product code for medi pneumatic compression system (pcs)-genius (Model 652)?

The FDA product code for medi pneumatic compression system (pcs)-genius (Model 652) is JOW.

Related Clinical Trials

NCT07613931 Evaluate Advanced Pneumatic Compression Device With Revised Compression Programming for Lymphedema Treatment NOT_YET_RECRUITING NCT03053791 Deep Brain Stimulation in Patients With Incomplete Spinal Cord Injury for Improvement of Gait RECRUITING NCT07609511 Magnet System Gastric Outlet Obstruction Study NOT_YET_RECRUITING NCT07409545 Autonomic Nervous System Intrapartum Monitoring to Prevent Neonatal Adverse Outcomes NOT_YET_RECRUITING NCT07603531 Assessment of the Efficacy of the Dynamic Decongestive System in the Maintenance Phase of Lower Limb Lymphedema NOT_YET_RECRUITING NCT07600489 A Randomized Non-Inferiority Study of Mepi™ Press 2 vs UrgoK2® for Compression Therapy in Venous Leg Ulcers NOT_YET_RECRUITING

Other Devices by Medi USA, LP

K183631medi pneumatic compression system (pcs) – brio (Model 651)

Related Devices (Code: JOW)

K163055Reprocessed Kendall SCD Express Foot CuffCovidien K160180Intermittent Pneumatic Compression systemDaesung Maref Co., Ltd. K161105Reprocessed Compression GarmentsCovidien K160431ActiveCare HomeMedical Compression Systems (Dbn) , Ltd. K161346NormaTec PCD-T and PCD-BNormaTec Industries, LP K161209Cirona 6400Devon Medical Products

Official Source

View on FDA Database →

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

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