SAEBO, INC.

Address:2459 Wilkinson Blvd.,CHARLOTTE,NC,28208,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

Electrode, Cutaneous (GXY) (3) System, Isokinetic Testing And Evaluation (IKK) (1)

Premarket Exempt

No Yes

Clear

SaeboRejoyce - 00850331006567 Catalog Number : K4-RJ-10---1

Device Description : Virtual-display arm rehabilitation system

Device Class : 2

Duns Number: 168569098

Premarket Exempt : Yes

Product Code : IKK

Prescription Use : No

Device Count : 1

SaeboTrodes Electrodes - 00850331006949 Catalog Number : K3-ST-10---4

Device Description : SaeboTrode Electrodes,Round 1.25", 1 pack, qty 4

Device Class : 2

Duns Number: 168569098

Premarket Exempt : No

Product Code : GXY

Prescription Use : No

Device Count : 1

SaeboTrodes Electrodes - 00850331006956 Catalog Number : K3-ST-20---4

Device Description : SaeboTrode Electrodes, Round, 2", 1 pack, Qty 4

Device Class : 2

Duns Number: 168569098

Premarket Exempt : No

Product Code : GXY

Prescription Use : No

Device Count : 1

SaeboTrodes Electrodes - 00850331006963 Catalog Number : K3-ST-30---4

Device Description : SaeboTrode Electrodes, Rectangular, 2" x 3.5", 1 pack, Qty 4

Device Class : 2

Duns Number: 168569098

Premarket Exempt : No

Product Code : GXY

Prescription Use : No

Device Count : 1

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