FDA.reportPublic FDA data

DALTON TACAHE HEAVY DUTY POWERCHAIR

Primary DI
00815027011768
Brand
DALTON TACAHE HEAVY DUTY POWERCHAIR
Company
DALTON MEDICAL CORPORATION
Model
PC1465-BL
Device description
TACAHE HEAVY DUTY POWERCHAIR, BLUE, WT. LIMIT 475 LBS.
Published
2016-09-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
ITIWheelchair, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITIWheelchair, PoweredPhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K052534000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K052534000TACAHEDalton Medical Corp.2006-01-27ITI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815027011768PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815027011768008150270117688150270117680815027011768

GMDN Terms#

Term, Definition table
TermDefinition
Wheelchair, power-assisted, occupant-controlled, collapsibleA wheeled personal mobility device that incorporates a seat-support system for a person with a disability or a person without the full capacity to walk (not bariatric) designed to be manually propelled and steered by the rotation of both rear wheels by the occupant, and when needed, power from an electric motor replaces manual wheel rotation. The device may be disassembled or folded for transport. Typically, the user is a paraplegic or quadriparetic person who desires to manually propel himself as much as possible for the exercise. The power assist feature is enabled to climb inclines, for extended distance travel, or when the user fatigues.

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
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
00815027012895DALTON FULL-ELECTRIC HOMECARE BEDBED54002026-02-27
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08436557351272BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351289BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351296BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351302BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351319BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351326BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351333BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351340BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351357BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351364BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351371BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351388BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351432BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351449BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351456BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351463BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351470BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351487BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351494BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351500BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351517BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351524BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351531BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351548BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351593BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351609BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351616BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351623BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351630BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351647BatecBATEC MOBILITY SL.ITI2026-07-29