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) (5) Walker, Mechanical (ITJ) (3) Lift, Patient, Non-Ac-Powered (FSA) (1) Table, Mechanical (INW) (1)

Premarket Exempt

Yes

Clear

Medium Pacer - 00858101008261 Catalog Number :

Device Description : Gait Trainer

Device Class : 1

Duns Number: 808251438

Premarket Exempt : Yes

Product Code : ITJ

Prescription Use : No

Device Count : 1

Large Pacer - 00858101008278 Catalog Number :

Device Description : Gait Trainer

Device Class : 1

Duns Number: 808251438

Premarket Exempt : Yes

Product Code : ITJ

Prescription Use : No

Device Count : 1

XL Pacer - 00858101008285 Catalog Number :

Device Description : Gait Trainer

Device Class : 1

Duns Number: 808251438

Premarket Exempt : Yes

Product Code : ITJ

Prescription Use : No

Device Count : 1

E-Pacer - 00858101008292 Catalog Number :

Device Description : Powered gait trainer and transfer device

Device Class : 1

Duns Number: 808251438

Premarket Exempt : Yes

Product Code : FSA

Prescription Use : No

Device Count : 1

Support Station - 00858101008322 Catalog Number :

Device Class : 1

Duns Number: 808251438

Premarket Exempt : Yes

Product Code : INW

Prescription Use : No

Device Count : 1

Small Right Arm Anchor - 00858101008339 Catalog Number :

Device Description : Arm Anchor

Device Class : 1

Duns Number: 808251438

Premarket Exempt : Yes

Product Code : KID

Prescription Use : No

Device Count : 1

Wrist Anchor - 00858101008346 Catalog Number :

Device Description : Arm Anchor

Device Class : 1

Duns Number: 808251438

Premarket Exempt : Yes

Product Code : KID

Prescription Use : No

Device Count : 1

Large Right Arm Anchor - 00858101008353 Catalog Number :

Device Description : Arm Anchor

Device Class : 1

Duns Number: 808251438

Premarket Exempt : Yes

Product Code : KID

Prescription Use : No

Device Count : 1

Large Left Arm Anchor - 00858101008360 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 Left Arm Anchor - 00858101008377 Catalog Number :

Device Description : Arm Anchor

Device Class : 1

Duns Number: 808251438

Premarket Exempt : Yes

Product Code : KID

Prescription Use : No

Device Count : 1

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