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

Bed, Ac-Powered Adjustable Hospital (FNL) (4) Vehicle, Motorized 3-Wheeled (INI) (2) Wheelchair, Mechanical (IOR) (2) Lift, Patient, Non-Ac-Powered (FSA) (1) Wheelchair, Powered (ITI) (1)

Premarket Exempt

No Yes

Clear

DALTON PATIENT LIFT - 00815027011416 Catalog Number :

Device Description : PATIENT LIFT, ELECTRIC, WT. LIMIT 600 lbs.

Device Class : 1

Duns Number: 874709348

Premarket Exempt : Yes

Product Code : FSA

Prescription Use : No

Device Count : 1

DALTON SCOOTER - 00815027011423 Catalog Number :

Device Description : ELECTRIC SCOOTER, 4 WHEEL, BLUE, WT. LIMIT 400 LBS.

Device Class : 2

Duns Number: 874709348

Premarket Exempt : No

Product Code : INI

Prescription Use : No

Device Count : 1

DALTON SCOOTER - 00815027011430 Catalog Number :

Device Description : ELECTRIC SCOOTER, 4 WHEEL, RED, WT. LIMIT 400 LBS.

Device Class : 2

Duns Number: 874709348

Premarket Exempt : No

Product Code : INI

Prescription Use : No

Device Count : 1

DALTON PRIMECHAIR - 00815027011447 Catalog Number :

Device Description : PRIMECHAIR POWERCHAIR, RED, WT. LIMIT 300 lbs.

Device Class : 2

Duns Number: 874709348

Premarket Exempt : No

Product Code : ITI

Prescription Use : No

Device Count : 1

DALTON MANUAL WHEELCHAIR - 00815027011454 Catalog Number :

Device Description : WHEELCHAIR, 16", MANUAL, W/FOOTREST, WT. LIMIT 250 LBS

Device Class : 1

Duns Number: 874709348

Premarket Exempt : No

Product Code : IOR

Prescription Use : No

Device Count : 1

DALTON HOMECARE LOW BED - 00815027011461 Catalog Number :

Device Description : HOMECARE LOW BED, 35" W x 88" L x 8.75"-17.75" H, WT. LIMIT 400 lbs. (WT. LIMIT HOMECARE LOW BED, 35" W x 88" L x 8.75"-17.75" H, WT. LIMIT 400 lbs. (WT. LIMIT INCLUDES PATIENT WEIGHT, MATTRESS WEIGHT, RAILS AND ANY ACCESSORIES).

Device Class : 2

Duns Number: 874709348

Premarket Exempt : Yes

Product Code : FNL

Prescription Use : No

Device Count : 1

DALTON MANUAL WHEELCHAIR - 00815027011478 Catalog Number :

Device Description : WHEELCHAIR,16", MANUAL,W/ LEGREST, WT. LIMIT 250LBS

Device Class : 1

Duns Number: 874709348

Premarket Exempt : No

Product Code : IOR

Prescription Use : No

Device Count : 1

DALTON SEMI-ELECTRIC HOMECARE BED - 00815027011485 Catalog Number :

Device Description : HOMECARE BED LIGHTWEIGHT, SEMI-ELECTRIC, WT. LIMIT 400 lbs. (Includes patient we HOMECARE BED LIGHTWEIGHT, SEMI-ELECTRIC, 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 BARIATRIC HOMECARE BED - 00815027011492 Catalog Number :

Device Description : HOMECARE BARIATRIC BED, Height 16” - 24.5," Dimensions 42”(W) x 88”(L), Wt Limit HOMECARE BARIATRIC BED, Height 16” - 24.5," Dimensions 42”(W) x 88”(L), Wt Limit 600 lbs. (Weight capacity includes patient weight, mattress weight, rails and any accessories).

Device Class : 2

Duns Number: 874709348

Premarket Exempt : Yes

Product Code : FNL

Prescription Use : No

Device Count : 1

DALTON HOMECARE BARIATRIC BED - 00815027011508 Catalog Number :

Device Description : HOMECARE BARIATRIC BED, HEIGHT 18.5"-26", DIMENSIONS: 48"(W) x 88"(L), WT LIMIT HOMECARE BARIATRIC BED, HEIGHT 18.5"-26", DIMENSIONS: 48"(W) x 88"(L), WT LIMIT 750 lbs. (WEIGHT LIMIT INCLUDES PATIENT WEIGHT, MATTRESS WEIGHT, RAILS AND ANY ACCESSORIES)

Device Class : 2

Duns Number: 874709348

Premarket Exempt : Yes

Product Code : FNL

Prescription Use : No

Device Count : 1

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