1BYONEPRODUCTS INC.

1BYONEPRODUCTS INC.

Address:1230 E Belmont Street,Ontario,CA,91761,US

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Filters

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) (5) Stimulator, Muscle, Powered, For Muscle Conditioning (NGX) (4) Pad, Heating, Powered (IRT) (2) Stimulator, Electrical, Transcutaneous, For Arthritis (NYN) (2) Stimulator, Nerve, Transcutaneous, Over-The-Counter (NUH) (2) Thermometer, Electronic, Clinical (FLL) (1)

Premarket Exempt

No

Clear

1BYONE - 00850014261016 Catalog Number :

Device Class :

Duns Number: 845019202

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

1BYONE - 00858069007009 Catalog Number :

Device Description : Electronic Pulse Stimulator Replacement Pads set of 3

Device Class : 2

Duns Number: 845019202

Premarket Exempt : No

Product Code : NGX

Prescription Use : No

Device Count : 1

1BYONE - 00858069007016 Catalog Number :

Device Description : Electronic Pulse Stimulator Replacement Pads 4x4cm

Device Class : 2

Duns Number: 845019202

Premarket Exempt : No

Product Code : NGX

Prescription Use : No

Device Count : 1

1BYONE - 00858069007030 Catalog Number :

Device Description : Wireless Arm Blood Pressure Monitor

Device Class : 2

Duns Number: 845019202

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

1byone - 00858069007054 Catalog Number :

Device Description : TOUCH-FREE INFRARED THERMOMETER- 4 in 1 Function : Forehead/Object/Night Mode/B TOUCH-FREE INFRARED THERMOMETER- 4 in 1 Function : Forehead/Object/Night Mode/Back Light- Measuring Range : 34~43℃- Operation Distance：1 inch (2.5cm)- 30-memory Recall- Fever Indication- ℃ / ℉ Switch-able Function- Battery: 2 “AAA” batteries

Device Class : 2

Duns Number: 845019202

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

1byone - 00858069007061 Catalog Number :

Device Class : 2

Duns Number: 845019202

Premarket Exempt : No

Product Code : NGX, IRT, NYN, NUH

Prescription Use : No

Device Count : 1

1byone - 00858069007085 Catalog Number :

Device Description : Two different size pads, one is 4*4 cm pad ( 4 pieces) one is big pad. ( 1 pieces)

Device Class :

Duns Number: 845019202

Premarket Exempt : No

Product Code : NGX, IRT, NYN, NUH

Prescription Use : No

Device Count : 1

1 BY ONE - 00858069007153 Catalog Number :

Device Class :

Duns Number: 845019202

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

1 BY ONE - 00858069007184 Catalog Number :

Device Class :

Duns Number: 845019202

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

1 BY ONE - 00858069007207 Catalog Number :

Device Class :

Duns Number: 845019202

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

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