Omron Healthcare, Inc.

Address:2895 Greenspoint Parkway,Hoffman Est,IL,60169,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

System, Measurement, Blood-Pressure, Non-Invasive (DXN) (6) Electrode, Cutaneous (GXY) (2) Analyzer, Body Composition (MNW) (1) Analyzer, Body Composition, Exempt (PUH) (1)

Premarket Exempt

No Yes

Clear

AC Adapter for HEM-907XL - 00073796149079 Catalog Number : HEM-ADPT907

Device Description : AC Adapter for HEM-907XL, Digital Blood Pressure Monitor

Device Class :

Duns Number: 054318779

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

Arm Cuff Standard D-Ring Cuff 9"-13" - 00073796173142 Catalog Number : H-CR17CAN

Device Description : Arm Blood Pressure Cuff, Standard D-ring (9" to 13")

Device Class :

Duns Number: 054318779

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

Comfit Cuff Preformed Large 9"-17" - 00073796223144 Catalog Number : H-CL22CAN

Device Description : Comfit Blood Pressure Cuff (Large 9" to 17")

Device Class :

Duns Number: 054318779

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

Omron Electrotherapy Pain Relief Long Life Pads - 00073796226145 Catalog Number : PMLLPAD

Device Description : Electrotherapy Pain Relief Long Life Pads

Device Class :

Duns Number: 054318779

Premarket Exempt : No

Product Code : GXY

Prescription Use : No

Device Count : 1

Omron Body Composition Monitor and Scale with Bluetooth - 00073796233501 Catalog Number : BCM-500

Device Description : Body composition monitor with scale and Bluetooth and smart tracking of 6 body metrics.

Device Class : 2

Duns Number: 054318779

Premarket Exempt : No

Product Code : PUH

Prescription Use : No

Device Count : 1

Omron Bronze Upper Arm Blood Pressure Monitor - 00073796251000 Catalog Number : BP5100

Device Description : Omron automatic digital upper arm blood pressure monitor with 14 reading memory storage

Device Class : 2

Duns Number: 054318779

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

HeartVue Wrist Blood Pressure Monitor - 00073796260002 Catalog Number :

Device Class : 2

Duns Number: 054318779

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

Omron Electrotherapy Pain Relief Long Life Pads - 00073796261429 Catalog Number : PMLLPAD-L

Device Description : Electrotherapy Pain Relief Long Life Pads

Device Class :

Duns Number: 054318779

Premarket Exempt : No

Product Code : GXY

Prescription Use : No

Device Count : 1

Omron Gold, Wrist Blood Pressure Monitor - 00073796264352 Catalog Number : BP4350

Device Description : Wrist Blood Pressure - 100 readings per user (2 users), Bluetooth Connectivity, Wrist Blood Pressure - 100 readings per user (2 users), Bluetooth Connectivity, Ultra Silent Inflation.

Device Class : 2

Duns Number: 054318779

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

Full Body Sensor Body Composition Monitor and Scale - 00073796265106 Catalog Number :

Device Class :

Duns Number: 054318779

Premarket Exempt : No

Product Code : MNW

Prescription Use : No

Device Count : 1

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