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FDA 510(k)

AIROS 8 Sequential Compression Device

K-Number: K193068 · 2019-12-04

ApplicantAiros Medical, Inc.
Decision Date2019-12-04
Product CodeJOW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AIROS 8 Sequential Compression Device is a medical device manufactured by Airos Medical, Inc.. It received FDA 510(k) clearance on 2019-12-04 under approval number K193068. 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 AIROS 8 Sequential Compression Device?

AIROS 8 Sequential Compression Device is a medical device that received FDA 510(k) clearance on 2019-12-04. It is manufactured by Airos Medical, Inc.. The 510(k) number is K193068.

When was AIROS 8 Sequential Compression Device approved by the FDA?

AIROS 8 Sequential Compression Device received FDA 510(k) clearance on 2019-12-04, under approval number K193068.

What company makes AIROS 8 Sequential Compression Device?

AIROS 8 Sequential Compression Device is manufactured by Airos Medical, Inc..

What is the FDA product code for AIROS 8 Sequential Compression Device?

The FDA product code for AIROS 8 Sequential Compression Device is JOW.

Related Clinical Trials

NCT07613931 Evaluate Advanced Pneumatic Compression Device With Revised Compression Programming for Lymphedema Treatment NOT_YET_RECRUITING NCT07603531 Assessment of the Efficacy of the Dynamic Decongestive System in the Maintenance Phase of Lower Limb Lymphedema NOT_YET_RECRUITING NCT07305870 Sequential Compression Device in Distributive Peripheral Edema and Hemodynamic Stability Among Patients in Critical Care Units ENROLLING_BY_INVITATION NCT07600489 A Randomized Non-Inferiority Study of Mepi™ Press 2 vs UrgoK2® for Compression Therapy in Venous Leg Ulcers NOT_YET_RECRUITING NCT07573189 The Effects of Recovery Compression Boots on Blood Lactate Levels, Functional Movement, and Joint Ange of Motion in Collegiate Athletes. ACTIVE_NOT_RECRUITING NCT06911385 Augmenting Cerebral Blood Flow in Acute Ischemic Stroke NOT_YET_RECRUITING

Other Devices by Airos Medical, Inc.

K172779AIROS 8 Sequential Compression Device K172770AIROS 6 Sequential Compression Device K193069AIROS 6 Sequential Compression Device K223193AIROS 8P Sequential Compression Device K223195AIROS 6P Sequential Compression Device K240499ARTAIRA Arterial Compression Device (AACD01)

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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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