FDA.reportPublic FDA data

TransMotionMedical

Primary DI
00810051740080
Brand
TransMotionMedical
Company
WINCO MFG., LLC
Model
S675
Catalog number
MC675CL
Device description
Stretcher, Wheeled, Powered, 675lb Max
Published
2020-05-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
INKStretcher, Wheeled, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
INKStretcher, Wheeled, PoweredPhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K110671000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K110671000WINCO STRETCHAIRWinco Mfg., LLC2011-04-22INK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810051740080PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810051740080008100517400808100517400800810051740080

GMDN Terms#

Term, Definition table
TermDefinition
Mobile bariatric examination/treatment chair, electricA mobile (on wheels) electronic device designed to support in a seated position an ambulatory or non-ambulatory bariatric (obese) patient, whose body mass exceeds the safe working load of a standard hospital/institution chair (e.g., around 350 kg), for examination/treatment. It incorporates a heavy-duty framework, extra wide seat-support for the patient, and an integrated rechargeable battery pack that powers electromotive functions (e.g., raise/lower/tilt/adjustment functions, motorized wheels). It is designed to be moved by healthcare professional for patient transport to a site for patient support without transfer during outpatient examination/treatment (e.g., surgical, dental, ENT).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8002373377customerservice@wincomfg.com

Regulatory Flags#

DUNS number
963886457
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00855630004498TMMS400S4002018-12-07
00810051740004Winco5P40 Vero5P402020-04-29
00810051740011Winco5P43 Vero5P432020-04-29
00810051740028Winco5P44 Vero5P442020-04-29
00810051740035Winco5P48 Vero5P482020-04-29
00810051740042Winco5P50 Vero5P502020-04-29
00810051740059Winco5P53 Vero5P532020-04-29
00810051740066Winco5P54 Vero5P542020-04-29
00810051740073Winco5P58 Vero5P582020-04-29
00855630004764Winco6P00 Vero6P002020-04-29
00855630004771Winco6P03 Vero6P032020-04-29
00855630004788Winco6P04 Vero6P042020-04-29
00855630004795Winco6P08 Vero6P082020-04-29
00855630004801Winco6P10 Vero6P102020-04-29
00855630004818Winco6P13 Vero6P132020-04-29
00855630004825Winco6P14 Vero6P142020-04-29
00855630004832Winco6P18 Vero6P182020-04-29
00855630004849Winco6P40 Vero6P402020-04-29
00855630004856Winco6P43 Vero6P432020-04-29
00855630004863Winco6P44 Vero6P442020-04-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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08592654407868Sprint 200L I N E T spol. s r.o.INK2023-09-07
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08592654389102Sprint 200L I N E T spol. s r.o.INK2023-04-14
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08592654387870Sprint 200L I N E T spol. s r.o.INK2023-01-27
08592654356678Sprint 200L I N E T spol. s r.o.INK2022-11-10
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07613327175226NASTRYKER CORPORATIONINK2020-09-25
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07613327283266HAVASUSTRYKER CORPORATIONINK2020-09-18
07613327282573HAVASUSTRYKER CORPORATIONINK2020-09-14
07613327504866NASTRYKER CORPORATIONINK2020-09-14
07613327261233NASTRYKER CORPORATIONINK2020-09-10
07613327261240NASTRYKER CORPORATIONINK2020-09-10
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07613327261301NASTRYKER CORPORATIONINK2020-09-10