LEXINGTON WELLNESS HOLDINGS INC.

LEXINGTON WELLNESS HOLDINGS INC.

Address:211 E. 43rd St.,New York,NY,10017,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

Analyzer, Body Composition, Exempt (PUH) (4) Glucose Oxidase, Glucose (CGA) (2) Oximeter (DQA) (1) System, Measurement, Blood-Pressure, Non-Invasive (DXN) (1) System, Test, Blood Glucose, Over The Counter (NBW) (1)

Premarket Exempt

No Yes

Clear

IdealSmart - 00834450009142 Catalog Number :

Device Description : Body composition scale.

Device Class : 2

Duns Number: 079437338

Premarket Exempt : Yes

Product Code : PUH

Prescription Use : No

Device Count : 1

Scan - 00860005561704 Catalog Number :

Device Description : Blood glucose meter test strips.

Device Class :

Duns Number: 079437338

Premarket Exempt : No

Product Code : CGA

Prescription Use : No

Device Count : 1

Touch - 00860005561728 Catalog Number :

Device Description : Pulse oximeter.

Device Class : 2

Duns Number: 079437338

Premarket Exempt : No

Product Code : DQA

Prescription Use : No

Device Count : 1

Balance - 00863398000249 Catalog Number :

Device Description : Body composition scale.

Device Class : 2

Duns Number: 079437338

Premarket Exempt : Yes

Product Code : PUH

Prescription Use : No

Device Count : 1

Balance - 00863398000263 Catalog Number :

Device Description : Body composition scale.

Device Class : 2

Duns Number: 079437338

Premarket Exempt : Yes

Product Code : PUH

Prescription Use : No

Device Count : 1

Balance - 00863398000270 Catalog Number :

Device Description : Body composition scale.

Device Class :

Duns Number: 079437338

Premarket Exempt : Yes

Product Code : PUH

Prescription Use : No

Device Count : 1

Beat - 00863398000287 Catalog Number :

Device Description : Upper arm blood pressure monitor.

Device Class : 2

Duns Number: 079437338

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

Scan - 00863398000294 Catalog Number :

Device Description : Blood glucose meter.

Device Class :

Duns Number: 079437338

Premarket Exempt : No

Product Code : CGA, NBW

Prescription Use : No

Device Count : 1

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