FDA.reportPublic FDA data

CTM Power Chair

Primary DI
00852202007444
Brand
CTM Power Chair
Company
C.T.M. HOMECARE PRODUCT, INC.
Model
HS-5600
Device description
Heavy Duty Rear-Wheels-Operated Power Chair, Red/Blue/Silver
Published
2018-12-27
Public version status
Update
Distribution status
Not 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
K002983000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K002983000C.T.M. POWER CHAIR, MODEL HS-5600Warepalmy Enterprise, LLC (Usa)2000-10-11ITI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00852202007444PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852202007444008522020074448522020074440852202007444

GMDN Terms#

Term, Definition table
TermDefinition
Wheelchair, electric-motor-driven, occupant-controlled, powered-steering, non-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 propelled by power from one or more electric motor(s). The electronic control of speed and direction are performed by the occupant of the device. The device cannot be folded or readily dismantled for transport.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
043045660
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00852202007031CTM Mobility ScooterHS-2682020-01-14
00852202007017CTM Mobility ScooterHS-1152019-06-14
00852202007000CTM Mobility ScooterHS-1182018-12-27
00852202007024CTM Mobility ScooterHS-1252018-12-27
00852202007048CTM Mobility ScooterHS-2652018-12-27
00852202007062CTM Mobility ScooterHS-2952018-12-27
00852202007086CTM Mobility ScooterHS-3202018-12-27
00852202007116CTM Mobility ScooterHS-3282018-12-27
00852202007147CTM Mobility ScooterHS-3602018-12-27
00852202007178CTM Mobility ScooterHS-5702018-12-27
00852202007208CTM Mobility ScooterHS-5802018-12-27
00852202007239CTM Mobility ScooterHS-7302018-12-27
00852202007260CTM Mobility ScooterHS-7402018-12-27
00852202007291CTM Mobility ScooterHS-8902018-12-27
00852202007321CTM Power ChairHS-10002018-12-27
00852202007352CTM Power ChairHS-15002018-12-27
00852202007383CTM Power ChairHS-28002018-12-27
00852202007413CTM Power ChairHS-28502018-12-27
00852202007475CTM Power ChairHS-62002018-12-27

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Primary DI, Brand, Company table
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