PMI

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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

Bed, Ac-Powered Adjustable Hospital (FNL) (3) Electrode, Cutaneous (GXY) (1)

Premarket Exempt

Yes No

Clear

PMI Probasics® - 00841447104544 Catalog Number : 0069

Device Description : Electrodes Pregelled (4 per package)

Device Class : 2

Duns Number: 005249268

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

PMI Probasics® - 00841447104551 Catalog Number : HBSMD

Device Description : Single Motor Semi-Electric Home Care Bed

Device Class : 2

Duns Number: 005249268

Premarket Exempt : Yes

Product Code : FNL

Prescription Use : No

Device Count : 1

PMI Probasics® - 00841447104568 Catalog Number : 6010PMI

Device Description : Foot Spring Section with Motor for Single Motor Bed

Device Class : 2

Duns Number: 005249268

Premarket Exempt : Yes

Product Code : FNL

Prescription Use : No

Device Count : 1

PMI Probasics® - 00841447104575 Catalog Number : HB5LBX

Device Description : Full Electric Low Bed

Device Class : 2

Duns Number: 005249268

Premarket Exempt : Yes

Product Code : FNL

Prescription Use : No

Device Count : 1

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