FDA.reportPublic FDA data

Alleset

Primary DI
06931918154186
Brand
Alleset
Company
GRI Medical & Electronic Technology Co., Ltd.
Model
Model GWC1616-2-COVER
Device description
Gel Wheelchair Cover_black_16inx16inx3in_50ea/cs
Published
2021-02-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IMPCUSHION, WHEELCHAIR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IMPCushion, WheelchairPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16931918154183PrimaryGS10
06931918154186Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1693191815418316931918154183
06931918154186069319181541866931918154186

GMDN Terms#

Term, Definition table
TermDefinition
Medical cushion coverA device intended to cover a medical cushion (e.g., birthing cushion, lumbar cushion, wheelchair cushion) during use to protect the cushion from dirt/debris to maintain hygiene. It may be dedicated to a specific type of cushion or non-dedicated; it is not intended for surgical use and is not intended to cover a pillow primarily used in bed. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+86057383617385link_dong@gri-metc.com

Regulatory Flags#

DUNS number
679894738
Device count
50
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
26931918108718AllesetAGH1X5002026-03-16
06931918122109Alleset15-0500-C2026-02-13
26931918173501Invenioi80-11114G-S2026-02-13
26931918101047AllesetSM5052026-02-09
26931918108411AllesetSM4042026-02-09
26931918139798Alleset99-UPSE2436-N2026-02-09
26931918152353AllesetSM3032026-02-09
26931918161324AllesetSM1012026-02-09
26931918171170AllesetMV-0796EV-S2026-02-09
26931918172931AllesetSM2022026-02-09
26931918141807Alleset44-0796PV-VE-S12026-02-05
26931918105694InvenioGOL0602026-01-21
16931918108155Alleset41-54542026-01-21
26931918125968AllesetCS-6512026-01-21
26931918143498AllesetCS-6502026-01-21
06931918157019Alleset30-015142026-01-21
16931918174334Alleset70-501322026-01-21
26931918184279AllesetCS-6522026-01-21
06931918102354Alleset25-0005-BL-C2025-12-16
26931918171255AllesetC-2015-NS2025-12-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00016958061888JAY LITEPRO CUSHIONSUNRISE MEDICAL (US) LLCIMP2026-03-05
H933EZ161896Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IMP2026-02-26
40080196312277MEDLINEMEDLINE INDUSTRIES, INC.IMP2026-02-04
09420051799745Spex SeatingSPEX LIMITEDIMP2025-12-12
09420051799752Spex SeatingSPEX LIMITEDIMP2025-12-12
09420051799769Spex SeatingSPEX LIMITEDIMP2025-12-12
09420051799776Spex SeatingSPEX LIMITEDIMP2025-12-12
09420051799783Spex SeatingSPEX LIMITEDIMP2025-12-12
09420051799790Spex SeatingSPEX LIMITEDIMP2025-12-12
09420051799820Spex SeatingSPEX LIMITEDIMP2025-12-12
09420051799837Spex SeatingSPEX LIMITEDIMP2025-12-12
09420051799844Spex SeatingSPEX LIMITEDIMP2025-12-12
09420051799738Spex LimitedSPEX LIMITEDIMP2025-12-05
09420051799806Spex LimitedSPEX LIMITEDIMP2025-12-05
09420051799813Spex LimitedSPEX LIMITEDIMP2025-12-05
08717261074016Vicair 4 ZV 18x18x3.25"Vicair B.V.IMP2025-12-03
00860014212307Matrix AIREZ Custom BackMatrix Seating USA, LLCIMP2025-11-19
00860014212314Matrix AIREZ Custom CushionMatrix Seating USA, LLCIMP2025-11-19
00860014212321Matrix Custom Seat CushionMatrix Seating USA, LLCIMP2025-11-19
00860010877449Ease CushionEase Seating SystemsIMP2025-09-05
00860010877456Ease CushionEase Seating SystemsIMP2025-09-05
00860010877463Ease CushionEase Seating SystemsIMP2025-09-05
00860010877470Ease CushionEase Seating SystemsIMP2025-09-05
00840117321915DMECare Solutions Ever-Soft Lumbar Support Cushion,18"Dynarex CorporationIMP2025-08-22
00840117321939DMECare Solutions Ever-Soft Lumbar Support Cushion, 20" Dynarex CorporationIMP2025-08-22
00840117321953DMECare Solutions Ever-Soft Lumbar Support Cushion, 22"Dynarex CorporationIMP2025-08-22
09420082600096Spex LimitedSPEX LIMITEDIMP2025-05-31
09420082600133Spex LimitedSPEX LIMITEDIMP2025-05-31
09420082600065Spex LimitedSPEX LIMITEDIMP2025-05-30
09420082600072Spex LimitedSPEX LIMITEDIMP2025-05-30