Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

COMFORT-AIRE

K-Number: K905126 · 1990-12-19

ApplicantAdvanced Air Dynamics, Inc.
Decision Date1990-12-19
Product CodeIOQ
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

COMFORT-AIRE is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Air Dynamics, Inc.. It received FDA 510(k) clearance on 1990-12-19 under 510(k) number K905126. The device is classified under product code IOQ. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COMFORT-AIRE?

COMFORT-AIRE is a medical device that received FDA 510(k) clearance on 1990-12-19. The listed applicant is Advanced Air Dynamics, Inc.. The 510(k) number is K905126.

When did COMFORT-AIRE receive FDA 510(k) clearance?

COMFORT-AIRE received FDA 510(k) clearance on 1990-12-19, under 510(k) number K905126.

Who is the listed applicant for COMFORT-AIRE?

The FDA 510(k) record lists Advanced Air Dynamics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COMFORT-AIRE?

The FDA product code for COMFORT-AIRE is IOQ.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Related Devices (Code: IOQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K122473TOTALCARE SPOT TOTALCARE BARIATRIC TOTALCARE DUO TOATALCARE BED SYSTEM TOTALCARE DUO2Hill-RomK973624NURSE'S AID PATIENT ROTATION SYSTEMAir Med Assist ProductsK970363HYDROTEC LOW AIR LOSS THERAPY BEDApex Metal, Inc.K970364AIRTEC2 LOW AIR LOSS THERAPY BEDApex Metal, Inc.K970636TOTALCARE., MODULAR THERAPY SYSTEM (MTS)Hill-Rom, Inc.K964873SILKAIR LOW AIRLOSS THERAPYHill-Rom, Inc.

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.

↑