Hovertech International

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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

DEVICE, PATIENT TRANSFER, POWERED (FRZ) (10) LIFT, PATIENT, AC-POWERED (FNG) (7)

Premarket Exempt

No Yes

Clear

Single Patient Use HoverMatt - 00816299011142 Catalog Number : HM34SPU-LNK-B

Device Description : 34" Single Patient Use HoverMatt LINK Breathable

Device Class : 2

Duns Number: 942139841

Premarket Exempt : Yes

Product Code : FRZ

Prescription Use : No

Device Count : 1

Single Patient Use HoverMatt - 00816299011166 Catalog Number : HM39SPU-LNK-B

Device Description : 39" Single Patient Use HoverMatt LINK Breathable

Device Class : 2

Duns Number: 942139841

Premarket Exempt : Yes

Product Code : FRZ

Prescription Use : No

Device Count : 1

Single Patient Use HoverMatt - 00816299011180 Catalog Number : HM50SPU-LNK-B

Device Description : 50" Single Patient Use HoverMatt LINK Breathable

Device Class : 2

Duns Number: 942139841

Premarket Exempt : Yes

Product Code : FRZ

Prescription Use : No

Device Count : 1

HoverTech Air Supply - 00816299011203 Catalog Number : AIR200G

Device Description : 800W HoverTech Air Supply

Device Class : 2

Duns Number: 942139841

Premarket Exempt : Yes

Product Code : FRZ, FNG

Prescription Use : No

Device Count : 1

HoverTech Air Supply - 00816299011210 Catalog Number : AIR400G

Device Description : 1100W HoverTech Air Supply

Device Class : 2

Duns Number: 942139841

Premarket Exempt : Yes

Product Code : FRZ, FNG

Prescription Use : No

Device Count : 1

HoverTech Air Supply - 00816299011227 Catalog Number : HTAIR1000

Device Description : 100V, 50/60Hz HTAIR HoverTech Air Supply

Device Class : 2

Duns Number: 942139841

Premarket Exempt : Yes

Product Code : FRZ, FNG

Prescription Use : No

Device Count : 1

HoverTech Air Supply - 00816299011234 Catalog Number : HTAIR1200

Device Description : 120V, 60Hz HTAIR HoverTech Air Supply

Device Class : 2

Duns Number: 942139841

Premarket Exempt : Yes

Product Code : FRZ, FNG

Prescription Use : No

Device Count : 1

HoverTech Air Supply - 00816299011241 Catalog Number : HTAIR2300

Device Description : 230V, 50Hz HTAIR HoverTech Air Supply

Device Class : 2

Duns Number: 942139841

Premarket Exempt : Yes

Product Code : FRZ, FNG

Prescription Use : No

Device Count : 1

HoverTech Air Supply - 00816299011258 Catalog Number : HTAIR2356

Device Description : 230V, 50/60Hz HTAIR HoverTech Air Supply

Device Class : 2

Duns Number: 942139841

Premarket Exempt : Yes

Product Code : FRZ, FNG

Prescription Use : No

Device Count : 1

SizeWise Air Supply - 00816299011265 Catalog Number : SW400AIR

Device Description : 1100W SizeWise Air Supply

Device Class : 2

Duns Number: 942139841

Premarket Exempt : Yes

Product Code : FNG, FRZ

Prescription Use : No

Device Count : 1

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