AIROS MEDICAL INC

FDA Device Registration & Listing · Audubon, PA, US · Registration 3014491159

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3014491159
FEI Number
3014491159
Entity Name
AIROS MEDICAL INC
City/State/Country
Audubon, PA, US
Establishment Address
2501 MONROE BLVD STE 1200, Audubon, PA 19403, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
AIROS Medical, Inc. (Owner Number: 10058005)
Owner / Operator Contact Address
2501 Monroe Blvd, Suite 1200, Audubon, PA 19403, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K240499
PMA Number
N/A

All Registered Proprietary Names

CircuFlow 5150 Sequential Compression Device AIROS 6 Sequential Compression Device AIROS 8 Sequential Compression Device AIROS 6 Sequential Compression Device CircuFlow 5208 Sequential Compression Device Circuflow 5202 Sequential Compression Device CircuFlow 5200 Sequential Compression Device AIROS 8P Sequential Compression Device AIROS 8 Sequential Compression Device

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
JOW Sleeve, Limb, Compressible Cardiovascular Class 2 870.5800 2018-10-24
JOW Sleeve, Limb, Compressible Cardiovascular Class 2 870.5800 2019-12-09
JOW Sleeve, Limb, Compressible Cardiovascular Class 2 870.5800 2019-12-09
JOW Sleeve, Limb, Compressible Cardiovascular Class 2 870.5800 2018-06-25
JOW Sleeve, Limb, Compressible Cardiovascular Class 2 870.5800 2018-10-24
JOW Sleeve, Limb, Compressible Cardiovascular Class 2 870.5800 2018-10-24
JOW Sleeve, Limb, Compressible Cardiovascular Class 2 870.5800 2023-01-05
JOW Sleeve, Limb, Compressible Cardiovascular Class 2 870.5800 2018-06-25
JOW Sleeve, Limb, Compressible Cardiovascular Class 2 870.5800 2024-10-14

Official Correspondent

Darren Behuniak

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

AIROS Medical, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K170216 Tactile Systems Technology, Inc. (Dba Tactile Medical) Flexitouch System 2017-05-26
K100306 Covidien KENDALL SCD SEQUENTIAL COMPRESSION COMFORT SLEEVES 2010-05-04

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3009155917 GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED Shenzhen Guangdong, CN
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014491159. Last updated year: 2026. Please use registration number 3014491159 when referencing this establishment in official correspondence.
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