FDA.reportPublic FDA data

Posture-Mate

Primary DI
00850016369451
Brand
Posture-Mate
Company
IMMERSUS HEALTH COMPANY, LLC
Model
"HB 20"" System Complete"
Catalog number
2229
Device description
"2229 Posture-Mate HB 20"" System Complete"
Published
2020-02-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00850016369451PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850016369451008500163694518500163694510850016369451

GMDN Terms#

Term, Definition table
TermDefinition
Wheelchair cushionA padded device designed to provide support, comfort, and assistance to the occupant of a wheelchair. It may be used to improve posture, provide back and/or side support, compensate for seat height, relieve stress points, and provide pressure alleviation for the buttocks, lumbar region, and the legs, and/or to provide an antislip mechanism. The device is typically situated behind the lower lumbar region of the back or under the buttocks and/or legs while the occupant is seated. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080627691
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
00850016369437Posture-Mate"HB 16"" System Complete"22212020-02-20
00850016369444Posture-Mate"HB 18"" System Complete"22252020-02-20
00850016369468Posture-Mate"HB 22"" System Complete"22332020-02-20
00850016369475Posture-Mate"WC 16"" System Complete"22372020-02-20
00850016369482Posture-Mate"WC 18"" System Complete"22382020-02-20
00850016369499Posture-Mate"WC 20"" System Complete"22392020-02-20
00850016369505Posture-Mate"WC 22"" System Complete"22402020-02-20
00850016369512Posture-MateG System Complete22172020-02-20
00850016369529Posture-MateG Seat & Calf Assembly only2217-SC2020-02-20
00850016369536Posture-MateG Universal Arm Pad only2217-A2020-02-20
00850016369543Posture-MateG Back & Head Pillow Assembly only2217-BH2020-02-20
00850016369550Posture-Mate"WC 22"" Seat Cushion only"2244-S2020-02-20
00850016369567Posture-Mate"WC 22"" Back Cushion only"2244-B2020-02-20
00850016369574Posture-Mate"WC 22"" Calf Pad only"2244-C2020-02-20
00850016369581Posture-Mate"WC 20"" Seat Cushion only"2242-S2020-02-20
00850016369598Posture-Mate"WC 20"" Back Cushion only"2243-B2020-02-20
00850016369604Posture-Mate"WC 20"" Calf Pad only"2243-C2020-02-20
00850016369611Posture-Mate"HB 16"" Head Cushion only"2218-H2020-02-20
00850016369628Posture-Mate"HB 18"" Head Cushion only"2222-H2020-02-20
00850016369635Posture-Mate"WC 18"" Calf Pad only"2242-C2020-02-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10080196312276MEDLINEMEDLINE INDUSTRIES, INC.IMP2026-02-04
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