FDA.reportPublic FDA data

DALTON FULL-ELECTRIC HOMECARE BED

Primary DI
00815027012895
Brand
DALTON FULL-ELECTRIC HOMECARE BED
Company
DALTON MEDICAL CORPORATION
Model
BED5400
Device description
"HOMECARE BED, FULL-ELECTRIC 54"", WITH RAIL, WT. LIMIT 1000 lbs. (Includes patient weight, mattress, rails, proper positioning, realignment, transfer and overall care is 1000 pounds)."
Published
2026-02-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FNLBed, Ac-Powered Adjustable Hospital
LLIBed, Therapeutic, Ac-Powered, Adjustable Home-Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FNLBed, Ac-Powered Adjustable HospitalGeneral Hospital2
LLIBed, Therapeutic, Ac-Powered, Adjustable Home-UseGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815027012895PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815027012895008150270128958150270128950815027012895

GMDN Terms#

Term, Definition table
TermDefinition
Basic electric home bedA mains electricity (AC-powered) motorized bed designed to be used in the home by a patient for rest/sleep, and that provides the occupant with touch button adjustment possibilities. It typically includes a framework with wheels, a mattress support platform that can articulate, a headboard and footboard and a remote control to operate the electrical motors. The device typically raises the torso and/or legs to various heights. It may also include a heatable mattress and physical therapy pulsators.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
874709348
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00815027012628DALTON FULL-ELECTRIC HOMECARE BEDBED42002026-02-27
00815027012635DALTON FULL-ELECTRIC HOMECARE BEDBED48002026-02-27
00815027011867DALTON ROLLATOR AR-8411KDAR2025-10-28
00815027011881DALTON ROLLATOR AR-8411KDBL2025-10-28
00815027012871DALTON LOW AIR LOSS MATTRESS SYSTEMPM-XCEL5000TURN2025-10-28
00815027012888DALTON ROLLATOR AR-56430KDAR2025-10-28
00815027012703DALTON TRANSFER BENCHTB-5058-12025-09-18
00815027012741DALTON QUAD CANEA-QC4011SBK-42025-09-18
00815027012758DALTON TRANSFER BENCHTB-5006KDHD-22025-09-18
00815027012765DALTON SHOWER BENCHBS-5013A-22025-09-18
00815027012772DALTON YOUTH WALKERA-WA6107W-22025-09-18
00815027012789DALTON WALKER A-WA6006HD-22025-09-18
00815027012796DALTON WALKER A-WA6005HEM2025-09-18
00815027012819DALTON WALKER PLATFORMA-WPA6401-22025-09-18
00815027012826DALTON COMMODE CHAIRCOM-DA500-22025-09-18
00815027012833DALTON COMMODE CHAIRCOM-DA300-22025-09-18
00815027012840DALTON TOILET SEATBS-30271G-12025-09-18
00815027012864DALTON SHOWER BENCHBS-5004-42025-09-18
00815027012734DALTON OVERBED TABLEB-T3616ABS2025-09-17
00815027012420DALTON KNEE WALKERAKN411AR2025-07-17

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Primary DI, Brand, Company table
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