FDA.reportPublic FDA data

Wenzellite

Primary DI
00822383934396
Brand
Wenzellite
Company
Drive Devilbiss Healthcare
Model
NIB-0784
Device description
Wenzelite Seating & Positioning Product Description Multi Fit Headrest Pad
Published
2020-02-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
IMSSUPPORT, HEAD AND TRUNK, WHEELCHAIR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IMSSupport, Head And Trunk, WheelchairPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00822383934396PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00822383934396008223839343968223839343960822383934396

GMDN Terms#

Term, Definition table
TermDefinition
Wheelchair headrestA padded device attached to a wheelchair, typically with a long and sturdy metal insert, to provide the wheelchair occupant with a support upon which to rest the head. The device improves user comfort and may improve some user range of vision. Its exterior is typically made of tear-resistant polyurethane. This GMDN code will also include the extensions needed to attach this device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
867673159
Device count
1
Premarket exempt
true
Serial number
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00023601061102Carex Health BrandsFGR11000 00002016-10-07
00092237614419Roscoe MedicalHUM-ROS62018-12-19
50050428250391DRIVEMEDICAL7417372019-06-21
00311917192352Walgreens9847282019-06-21
00822383989815DRIVEMEDICAL146-RTLPC23201-M2019-06-21
00822383989839DRIVEMEDICAL146-RTLPC23201-F2019-06-21
00822383246420DriveRTLPC23201-F2017-05-19
00822383037127Silver SportBIN-SSP316DDA-SF2026-06-22
00822383037134Silver SportBIN-SSP218DDA-SF2026-06-22
00822383037141Silver SportBIN-SSP220DDA-SF2026-06-22
00822383037158Cruiser 3 16"BIN-K316ADDA-SF2026-06-22
00822383037165Cruiser 3 18"BIN-K318ADDA-SF2026-06-22
00822383037172Cruiser 3 20"BIN-K320ADDA-SF2026-06-22
00194346283439EquateEQKW5002026-06-10
10092237600105Roscoe MedicalEP4070WCD2016-10-18
90002360125501AccuReliefACRL-55002016-10-12
00009223761699Reliable MedicalEF2020BC2-TU2018-06-13
00009223761941EswallowESW-90502016-12-31
00023601005144CAREX HEALTH BRANDSFGA51400 00002022-12-20
00023601005151CAREX HEALTH BRANDSFGA51500 BLUE2022-12-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07540147004033Side Mount Headrest Interface PlateMotion Concepts IncIMS2026-05-19
10194484321953CONDORGRAINGER INTERNATIONAL, INC.IMS2025-12-22
10194484321960CONDORGRAINGER INTERNATIONAL, INC.IMS2025-12-22
10194484321977CONDORGRAINGER INTERNATIONAL, INC.IMS2025-12-22
10194484321984CONDORGRAINGER INTERNATIONAL, INC.IMS2025-12-22
10194484321991CONDORGRAINGER INTERNATIONAL, INC.IMS2025-12-22
10194484322004CONDORGRAINGER INTERNATIONAL, INC.IMS2025-12-22
10194484322011CONDORGRAINGER INTERNATIONAL, INC.IMS2025-12-22
10194484322028CONDORGRAINGER INTERNATIONAL, INC.IMS2025-12-22
10194484322035CONDORGRAINGER INTERNATIONAL, INC.IMS2025-12-22
10194484322042CONDORGRAINGER INTERNATIONAL, INC.IMS2025-12-22
10194484322059CONDORGRAINGER INTERNATIONAL, INC.IMS2025-12-22
10194484322073CONDORGRAINGER INTERNATIONAL, INC.IMS2025-12-22
10194484322080CONDORGRAINGER INTERNATIONAL, INC.IMS2025-12-22
10194484322097CONDORGRAINGER INTERNATIONAL, INC.IMS2025-12-22
10194484322103CONDORGRAINGER INTERNATIONAL, INC.IMS2025-12-22
10194484322110CONDORGRAINGER INTERNATIONAL, INC.IMS2025-12-22
10194484322127CONDORGRAINGER INTERNATIONAL, INC.IMS2025-12-22
10194484322134CONDORGRAINGER INTERNATIONAL, INC.IMS2025-12-22
10194484322141CONDORGRAINGER INTERNATIONAL, INC.IMS2025-12-22
10194484322158CONDORGRAINGER INTERNATIONAL, INC.IMS2025-12-22
10194484322165CONDORGRAINGER INTERNATIONAL, INC.IMS2025-12-22
10194484322189CONDORGRAINGER INTERNATIONAL, INC.IMS2025-12-22
10194484322196CONDORGRAINGER INTERNATIONAL, INC.IMS2025-12-22
10194484322202CONDORGRAINGER INTERNATIONAL, INC.IMS2025-12-22
10194484322219CONDORGRAINGER INTERNATIONAL, INC.IMS2025-12-22
10194484322226CONDORGRAINGER INTERNATIONAL, INC.IMS2025-12-22
10194484322233CONDORGRAINGER INTERNATIONAL, INC.IMS2025-12-22
10194484322240CONDORGRAINGER INTERNATIONAL, INC.IMS2025-12-22
10194484322257CONDORGRAINGER INTERNATIONAL, INC.IMS2025-12-22