IGEA SPA

Address:Via Parmenide, 10/A,Carpi (MO) Modena,IT

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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

Stimulator, Bone Growth, Non-Invasive (LOF) (5)

Premarket Exempt

Clear

AccelStim - 08050040997213 Catalog Number : 4300

Device Description : Bone Growth Stimulator

Device Class : 3

Duns Number: 429342710

Premarket Exempt : No

Product Code : LOF

Prescription Use : Yes

Device Count : 1

Accelstim - 08050040997299 Catalog Number : 654300-9001

Device Description : Replacement Ultrasound Gel, Accelstim 4300

Device Class : 3

Duns Number: 429342710

Premarket Exempt : No

Product Code : LOF

Prescription Use : Yes

Device Count : 1

Accelstim - 08050040997305 Catalog Number : 654300-8001

Device Description : Replacement Strap, Accelstim 4300

Device Class : 3

Duns Number: 429342710

Premarket Exempt : No

Product Code : LOF

Prescription Use : Yes

Device Count : 1

Accelstim - 08050040997312 Catalog Number : 654300-8002

Device Description : Replacement Transducer Holder, Accelstim 4300

Device Class : 3

Duns Number: 429342710

Premarket Exempt : No

Product Code : LOF

Prescription Use : Yes

Device Count : 1

Accelstim - 08050040997329 Catalog Number : 654300-9003

Device Description : Replacement Power Supply, Accelstim 4300

Device Class : 3

Duns Number: 429342710

Premarket Exempt : No

Product Code : LOF

Prescription Use : Yes

Device Count : 1

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