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, Mechanical (IOR) (3) Table, Mechanical (INW) (2) Wheelchair, Powered (ITI) (2) Bed, Ac-Powered Adjustable Hospital (FNL) (1) Mattress, Air Flotation, Alternating Pressure (FNM) (1) Vehicle, Motorized 3-Wheeled (INI) (1)

Premarket Exempt

No Yes

Clear

DALTON MANUAL WHEELCHAIR - 00815027011201 Catalog Number :

Device Description : WHEELCHAIR, MANUAL, 20" W/LEGREST, ADJUST HEIGHT ARM, WT LIMIT 250 LBS

Device Class : 1

Duns Number: 874709348

Premarket Exempt : No

Product Code : IOR

Prescription Use : No

Device Count : 1

DALTON MANUAL WHEELCHAIR RECLINER - 00815027011225 Catalog Number :

Device Description : WHEELCHAIR,MANUAL, 22" W/LEGREST, RECLINER, WT LIMIT 350 LBS

Device Class : 1

Duns Number: 874709348

Premarket Exempt : No

Product Code : IOR

Prescription Use : No

Device Count : 1

DALTON MANUAL WHEELCHAIR RECLINER - 00815027011232 Catalog Number :

Device Description : WHEELCHAIR, MANUAL, 24" W/LEGREST, RECLINER, WT LIMIT 370 LBS

Device Class : 1

Duns Number: 874709348

Premarket Exempt : No

Product Code : IOR

Prescription Use : No

Device Count : 1

DALTON LOW AIR LOSS MATTRESS SYSTEM - 00815027011348 Catalog Number :

Device Description : LOW AIR LOSS MATTRESS SYSTEM, WITH PUMP, WT. LIMIT 350 LBS.

Device Class : 2

Duns Number: 874709348

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

DALTON FIXED POSITION HOMECARE BED - 00815027011355 Catalog Number :

Device Description : SEMI-ELECTRIC FIXED POSITION BED, ONE MOTOR, WT. LIMIT 400 lbs. (Includes patien SEMI-ELECTRIC FIXED POSITION BED, ONE MOTOR, WT. LIMIT 400 lbs. (Includes patient weight, mattress, rails, proper positioning, realignment, transfer and overall care is 400 pounds).

Device Class : 2

Duns Number: 874709348

Premarket Exempt : Yes

Product Code : FNL

Prescription Use : No

Device Count : 1

DALTON OVERBED TABLE - 00815027011362 Catalog Number :

Device Description : OVERBED TABLE, NON-TILT

Device Class : 1

Duns Number: 874709348

Premarket Exempt : Yes

Product Code : INW

Prescription Use : No

Device Count : 1

DALTON OVERBED TABLE - 00815027011379 Catalog Number :

Device Description : OVERBED TABLE, TILT,

Device Class : 1

Duns Number: 874709348

Premarket Exempt : Yes

Product Code : INW

Prescription Use : No

Device Count : 1

SEGAEGO 4D SCOOTER - 00815027011386 Catalog Number :

Device Description : SEGAEGO 4D 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 TACAHE HEAVY DUTY POWERCHAIR - 00815027011393 Catalog Number :

Device Description : TACAHE HEAVY DUTY POWERCHAIR, RED, WT. LIMIT 600 LBS.

Device Class : 2

Duns Number: 874709348

Premarket Exempt : No

Product Code : ITI

Prescription Use : No

Device Count : 1

DALTON TACAHE HEAVY DUTY POWERCHAIR - 00815027011409 Catalog Number :

Device Description : TACAHE HEAVY DUTY POWERCHAIR, BLUE, WT. LIMIT 600 LBS.

Device Class : 2

Duns Number: 874709348

Premarket Exempt : No

Product Code : ITI

Prescription Use : No

Device Count : 1

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