APDM, INC.

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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

Exerciser, Measuring (ISD) (3)

Premarket Exempt

Yes

Clear

Access Point V2C - B628APV2C0 Catalog Number : APV2C

Device Description : APDM’s Access Point is an accessory that enables wireless streaming to a compute APDM’s Access Point is an accessory that enables wireless streaming to a computer for the Opal V2C.

Device Class : 2

Duns Number: 808473453

Premarket Exempt : Yes

Product Code : ISD

Prescription Use : Yes

Device Count : 1

Docking Station V2C - B628DSV2C0 Catalog Number : DSV2C

Device Description : APDM’s Docking Station is an accessory that transfers the raw sensor data logged APDM’s Docking Station is an accessory that transfers the raw sensor data logged to a computer for the Opal V2C. Additionally, the Docking Station recharges the battery of an Opal V2C.

Device Class : 2

Duns Number: 808473453

Premarket Exempt : Yes

Product Code : ISD

Prescription Use : Yes

Device Count : 1

Opal V2C - B628OPALV2C0 Catalog Number : OPALV2C

Device Description : APDM's Opal V2C is a small worn monitor designed for documenting physical moveme APDM's Opal V2C is a small worn monitor designed for documenting physical movement associated with applications in physiological monitoring. The Opal V2C can be used in any instance where quantifiable analysis of physical motion is desirable.

Device Class : 2

Duns Number: 808473453

Premarket Exempt : Yes

Product Code : ISD

Prescription Use : Yes

Device Count : 1

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