FDA.reportPublic FDA data

Coccyx Cushion - 16 x 16

Primary DI
00815067043552
Brand
Coccyx Cushion - 16 x 16
Company
COMPASS HEALTH BRANDS CORP.
Model
HDC-CX1616
Published
2020-11-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

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
30815067043553PackageGS14In Commercial Distribution
00815067043552PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3081506704355330815067043553
00815067043552008150670435528150670435520815067043552

GMDN Terms#

Term, Definition table
TermDefinition
Soft-rubber chair cushionA pad made of soft rubber designed to be placed on the seat of a chair to distribute an occupant's body weight over the surface of the buttocks, typically to relieve pressure points for comfort and to prevent pressure sores. It is commonly used for elderly immobilized patients especially in cases of decubitus ulcers, patients with disabilities, or patients with low body fat. It may be used in a wheelchair. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
4405721962customerservice@compasshealthbrands.com
800-376-7263customerservice@compasshealthbrands.com

Regulatory Flags#

DUNS number
827221698
Device count
1
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
00092237613269Roscoe MedicalLS52662016-10-13
00194346678921Equate73085EQ2026-03-09
00714905117649Fab StimDT30252026-02-06
00714905710024Fab StimDT70252026-02-06
00860163000312CMS DT30292026-02-06
00092237622209SCRIPHESSCO672-0192-CH2026-02-03
00092237622216SCRIPHESSCO672-0193-CH2026-02-03
00092237622339SCRIPHESSCO672-0195-CH2026-02-03
30194346615156Equate 72085EQ2026-01-20
00092237627495Roscoe MedicalO2C6P2026-01-15
00023601130402CarexFGB30400 00002025-12-01
00092237622193SCRIPHESSCO672-0010-CH2025-11-24
00714905710062FabStimE1P3000TC2FS2025-11-18
00092237621967TwinStimDS5002-OTC2025-09-29
00092237902257MicroBlock Antimicrobial Electrode400-877-MIC2020-06-11
00092237902240MicroBlock Antimicrobial Electrode400-872-MIC2019-01-08
00092237902288MicroBlock Antimicrobial Electrode400-852-MIC2020-06-11
00092237902264MicroBlock Antimicrobial Electrode400-879-MIC2020-06-11
00092237902271MicroBlock Antimicrobial Electrode400-881-MIC2020-06-11
00092237611531Roscoe MedicalLS52552016-10-13

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
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09420051799790Spex SeatingSPEX LIMITEDIMP2025-12-12
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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