FDA.report

510(k) K240499

Device
ARTAIRA Arterial Compression Device (AACD01)
Applicant
Airos Medical, Inc.
510(k) number
K240499
Product code
JOW
Decision
Substantially Equivalent (SESE)
Decision date
2024-10-11
Date received
2024-02-20
Regulation
870.5800
Classification name
Sleeve, Limb, Compressible
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Darren Behuniak
Address
2501 Monroe Blvd. Suite 1200 Audubon PA US 19403 19403

FDA Registration Numbers

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code JOW

510(k)DeviceApplicantDecision date
K250242Compression Therapy Device (LGT-2202DVT)Guangzhou Longest Medical Technology Co., Ltd.2026-04-24
K254267NanoPress 760A-BT (760A-BT)Mego Afek , Ltd.2026-02-24
K250974Bio Arterial Deluxe (IC-BAP-DX)Bio Compression Systems, Inc.2025-12-12
K250190Sequential Compression System (SCD600)Shenzhen Comen Medical Instruments Co.,Ltd2025-12-08
K251466VenAir, Sequential Compression System (9P-089000); VenAir, Sequential Compression System (PM01D01 / Calf garment (S)); VenAir, Sequential Compression System (PM01E01 / Calf garment (M)); VenAir, Sequential Compression System (PM01F01 / Calf garment (L)); VenAir, Sequential Compression System (PM01G01 / Thigh garment (S)); VenAir, Sequential Compression System (PM01H01 / Thigh garment (M)); VenAir, Sequential Compression System (PM01I01 / Thigh garment (L)); VenAir, Sequential ComprWellell, Inc.2025-10-28
K251446PlasmaFlow X Compression Sleeve Device (XPF0001)Manamed, LLC2025-09-17
K251086PnueAira (PNCU-01)Biotab, LLC2025-08-18
K250817Coretech Compression System (Coretech RHB3003)Vive Health, LLC2025-08-08
K241096Venera 608 Deep Vein Thrombosis (DVT) Prevention SystemSuzhou Minhua Medical Apparatus Supplies Co., Ltd.2025-01-15
K241746UMED REPROCESSED AIRCAST VENAFLOW FOOT CUFF; UMED REPROCESSED KENDALL SCD EXPRESS SLEEVE; UMED REPROCESSED AIRCAST ELITE CALF CUFF 3040 3050; UMED REPROCESSED CTC VP 501 CALF CUFF; UMED REPROCESSED CTC VP 520 FOOT CUFFUnited Medical Resources, LLC2024-10-04
K232640Venowave VW5Thermabright2024-06-25
K234155Nimbl (model PD08-N1)Tactile Medical2024-06-21
K240125Therm-X (Home); Therm-X (AT)Zenith Technical Innovations2024-06-21
K232270DVT Motion Pneumatic Compression DeviceKoge Micro Tech Co., Ltd.2024-03-06
K240011Lymphedema CompressionJkh Health Co., Ltd.2024-02-23