DALTON MEDICAL CORPORATION

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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

Wheelchair, Powered (ITI) (7) Vehicle, Motorized 3-Wheeled (INI) (2) Lift, Patient, Ac-Powered (FNG) (1)

Premarket Exempt

No Yes

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DALTON SCOOTER - 00815027011614 Catalog Number :

Device Description : ELECTRIC SCOOTER, 4 WHEEL, RED, WT. LIMIT 300 LBS.

Device Class : 2

Duns Number: 874709348

Premarket Exempt : No

Product Code : INI

Prescription Use : No

Device Count : 1

DALTON PRIMECHAIR - 00815027011621 Catalog Number :

Device Description : PRIMECHAIR MID-WHEEL DRIVE, RED, WT. LIMIT 300 lbs.

Device Class : 2

Duns Number: 874709348

Premarket Exempt : No

Product Code : ITI

Prescription Use : No

Device Count : 1

DALTON ELECTRIC SCOOTER - 00815027011645 Catalog Number :

Device Description : ELECTRIC SCOOTER, 4 WHEEL, RED, WT. LIMIT 250 lbs.

Device Class : 2

Duns Number: 874709348

Premarket Exempt : No

Product Code : INI

Prescription Use : No

Device Count : 1

DALTON PRIMECHAIR - 00815027011652 Catalog Number :

Device Description : PRIMECHAIR, LIGHTWEIGHT POWERCHAIR, RED, WT. LIMIT 250 LBS.

Device Class : 2

Duns Number: 874709348

Premarket Exempt : No

Product Code : ITI

Prescription Use : No

Device Count : 1

DALTON PRIMECHAIR - 00815027011669 Catalog Number :

Device Description : PRIMECHAIR, LIGHTWEIGHT POWERCHAIR, BLUE, WT. LIMIT 250 LBS.

Device Class : 2

Duns Number: 874709348

Premarket Exempt : No

Product Code : ITI

Prescription Use : No

Device Count : 1

DALTON PRIMECHAIR - 00815027011676 Catalog Number :

Device Description : PRIMECHAIR REAR WHEEL DRIVE, RED, WT. LIMIT 300 lbs.

Device Class : 2

Duns Number: 874709348

Premarket Exempt : No

Product Code : ITI

Prescription Use : No

Device Count : 1

DALTON PRIMECHAIR - 00815027011683 Catalog Number :

Device Description : PRIMECHAIR, REAR WHEEL DRIVE, BLUE, WT. LIMIT 300 lbs.

Device Class : 2

Duns Number: 874709348

Premarket Exempt : No

Product Code : ITI

Prescription Use : No

Device Count : 1

DALTON TACAHE MID-WHEEL DRIVE POWERCHAIR - 00815027011690 Catalog Number :

Device Description : TACAHE MID-WHEEL DRIVE POWERCHAIR, RED, WT. LIMIT 350 LBS.

Device Class : 2

Duns Number: 874709348

Premarket Exempt : No

Product Code : ITI

Prescription Use : No

Device Count : 1

DALTON TACAHE MID-WHEEL DRIVE POWERCHAIR - 00815027011706 Catalog Number :

Device Description : TACAHE MID-WHEEL DRIVE POWERCHAIR, BLUE, WT. LIMIT 350 LBS.

Device Class : 2

Duns Number: 874709348

Premarket Exempt : No

Product Code : ITI

Prescription Use : No

Device Count : 1

DALTON PATIENT LIFT - 00815027011713 Catalog Number :

Device Description : PATIENT LIFT, ELECTRIC, WT. LIMIT 400 lbs.

Device Class : 2

Duns Number: 874709348

Premarket Exempt : Yes

Product Code : FNG

Prescription Use : No

Device Count : 1

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