FDA.reportPublic FDA data

Winco

Primary DI
00855630004115
Brand
Winco
Company
WINCO MFG., LLC
Model
528
Catalog number
528
Device description
528 Drop Arm Convalescent Recliner (3 Positions/NO TRAY)
Published
2018-12-07
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
FRJChair, Geriatric

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRJChair, GeriatricGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00855630004115PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00855630004115008556300041158556300041150855630004115

GMDN Terms#

Term, Definition table
TermDefinition
General examination/treatment chair, manualA manually-operated device designed to support and position the patient in a seated or reclined posture for easy access and patient comfort during a diagnostic examination, medical treatment, and/or surgical procedure across specialties. It usually has moveable components and may include special features such as a raising and lowering mechanism and removable arms. For chairs involving the use of medical systems that emit and/or detect energy (e.g., ionizing or non-ionizing radiation, ultrasound, heat, light) see the respective chair terms for those systems.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-237-3377customer.service@wincomfg.com

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00855630004498TMMS400S4002018-12-07
00810051740080TransMotionMedicalS675MC675CL2020-05-05
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09343062022322Air ComfortK CARE HEALTHCARE SOLUTIONS PTY LTDFRJ2025-03-13
09343062029642Air ComfortK CARE HEALTHCARE SOLUTIONS PTY LTDFRJ2025-03-13
09343062029666Air ComfortK CARE HEALTHCARE SOLUTIONS PTY LTDFRJ2025-03-13
09343062031980Air ComfortK CARE HEALTHCARE SOLUTIONS PTY LTDFRJ2025-03-13
09343062031997Air ComfortK CARE HEALTHCARE SOLUTIONS PTY LTDFRJ2025-03-13
09343062032147Air ComfortK CARE HEALTHCARE SOLUTIONS PTY LTDFRJ2025-03-13
09343062033465Air ComfortK CARE HEALTHCARE SOLUTIONS PTY LTDFRJ2025-03-13
09343062033571Air ComfortK CARE HEALTHCARE SOLUTIONS PTY LTDFRJ2025-03-13
09343062033656Air ComfortK CARE HEALTHCARE SOLUTIONS PTY LTDFRJ2025-03-13
09343062036343Air ComfortK CARE HEALTHCARE SOLUTIONS PTY LTDFRJ2025-03-13
06975821401111UnixcareJiangyin Unixcare Medical Devices Co.,LtdFRJ2022-11-23
00853223008380MEDACUREMEDACURE INC.FRJ2020-10-01
00815027010587DALTON GERIATRIC RECLINERDALTON MEDICAL CORPORATIONFRJ2019-06-11
00815027010594DALTON GERIATRIC RECLINERDALTON MEDICAL CORPORATIONFRJ2019-06-11
00815027010600DALTON CLINICAL RECLINERDALTON MEDICAL CORPORATIONFRJ2019-06-11
00855630004085WincoWINCO MFG., LLCFRJ2018-12-07
00855630004092WincoWINCO MFG., LLCFRJ2018-12-07
00855630004108WincoWINCO MFG., LLCFRJ2018-12-07
00855630004122WincoWINCO MFG., LLCFRJ2018-12-07
00855630004139WincoWINCO MFG., LLCFRJ2018-12-07
00855630004146WincoWINCO MFG., LLCFRJ2018-12-07
00855630004153WincoWINCO MFG., LLCFRJ2018-12-07
00855630004160WincoWINCO MFG., LLCFRJ2018-12-07
00855630004177WincoWINCO MFG., LLCFRJ2018-12-07
00855630004184WincoWINCO MFG., LLCFRJ2018-12-07
00855630004191WincoWINCO MFG., LLCFRJ2018-12-07
00855630004207WincoWINCO MFG., LLCFRJ2018-12-07
00855630004214WincoWINCO MFG., LLCFRJ2018-12-07
00855630004221WincoWINCO MFG., LLCFRJ2018-12-07
00855630004238WincoWINCO MFG., LLCFRJ2018-12-07