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

Attachment, Commode, Wheelchair (INB) (1) Generator, Oxygen, Portable (CAW) (1) Walker, Mechanical (ITJ) (1)

Premarket Exempt

No Yes

Clear

DALTON ROLLATOR - 00815027012253 Catalog Number :

Device Description : ROLLATOR, LIGHT WEIGHT, 6" WHEEL, HAND BRAKES, BLACK, WT LIMIT 220 LBS

Device Class : 1

Duns Number: 874709348

Premarket Exempt : Yes

Product Code : ITJ

Prescription Use : No

Device Count : 1

DALTON REHAB SHOWER COMMODE CHAIR - 00815027012260 Catalog Number :

Device Description : REHAB SHOWER COMMODE CHAIR,PADDED SEAT,FOOTREST,24" REAR WHEELS,WT LIMIT 230 LBS

Device Class : 1

Duns Number: 874709348

Premarket Exempt : Yes

Product Code : INB

Prescription Use : No

Device Count : 1

DALTON OXYGEN CONCENTRATOR - 00815027012376 Catalog Number :

Device Description : OXYGEN CONCENTRATOR 5 LITER.

Device Class : 2

Duns Number: 874709348

Premarket Exempt : No

Product Code : CAW

Prescription Use : No

Device Count : 1

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