RIFTON EQUIPMENT

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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

Restraint, Wheelchair, Non-Protective (KID) (4) Chair, Adjustable, Mechanical (INN) (3) Exerciser, Non-Measuring (ION) (3)

Premarket Exempt

Yes

Clear

Right Elbow Anchor - 00858101008384 Catalog Number :

Device Description : Arm Anchor

Device Class : 1

Duns Number: 808251438

Premarket Exempt : Yes

Product Code : KID

Prescription Use : No

Device Count : 1

Left Elbow Anchor - 00858101008391 Catalog Number :

Device Description : Arm Anchor

Device Class : 1

Duns Number: 808251438

Premarket Exempt : Yes

Product Code : KID

Prescription Use : No

Device Count : 1

Hand Anchor - 00858101008407 Catalog Number :

Device Description : Arm Anchor

Device Class : 1

Duns Number: 808251438

Premarket Exempt : Yes

Product Code : KID

Prescription Use : No

Device Count : 1

Horizontal Anchor - 00858101008414 Catalog Number :

Device Description : Arm Anchor

Device Class : 1

Duns Number: 808251438

Premarket Exempt : Yes

Product Code : KID

Prescription Use : No

Device Count : 1

Small Tricycle - 00858101008513 Catalog Number :

Device Description : Adaptive Tricycle

Device Class : 1

Duns Number: 808251438

Premarket Exempt : Yes

Product Code : ION

Prescription Use : No

Device Count : 1

Medium Tricycle - 00858101008537 Catalog Number :

Device Description : Adaptive Tricycle

Device Class : 1

Duns Number: 808251438

Premarket Exempt : Yes

Product Code : ION

Prescription Use : No

Device Count : 1

Large Tricycle - 00858101008544 Catalog Number :

Device Description : Adaptive Tricycle

Device Class : 1

Duns Number: 808251438

Premarket Exempt : Yes

Product Code : ION

Prescription Use : No

Device Count : 1

Rifton Activity Chair, Standard, Small - 00858101008599 Catalog Number :

Device Description : Activity chair

Device Class : 1

Duns Number: 808251438

Premarket Exempt : Yes

Product Code : INN

Prescription Use : No

Device Count : 1

Rifton Activity Chair, Hi-Lo, Small - 00858101008605 Catalog Number :

Device Description : Activity chair

Device Class : 1

Duns Number: 808251438

Premarket Exempt : Yes

Product Code : INN

Prescription Use : No

Device Count : 1

Rifton Activity Chair, Standard, Medium - 00858101008612 Catalog Number :

Device Description : Activity chair

Device Class : 1

Duns Number: 808251438

Premarket Exempt : Yes

Product Code : INN

Prescription Use : No

Device Count : 1

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