FDA.reportPublic FDA data

Assembly Set (18-42 cm), Black

Primary DI
04064406089874
Brand
Assembly Set (18-42 cm), Black
Company
Otto Bock Mobility Solutions GmbH
Model
476D52=SK035
Published
2023-12-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
KNOAccessories, Wheelchair

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNOAccessories, WheelchairPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04064406089874PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04064406089874040644060898744064406089874

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
341148586
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04032767034376Arm Support Offset Plate436H1=72024-04-09
04032767350711Kit for nut-modular armrest437A402024-04-09
04032767358595Heavy Duty Clamp complete, Black477L52=SK0552024-04-09
04064406193656Paragolfer Power Wheelchair490E54=00000_K2020-09-15
04064406089836Clinical Assembly Set (43-53cm), Black476D52=SK0152023-12-19
04064406089850Clinical Assembly Set (54-64cm), Black476D52=SK0252023-12-19
04064406089898Assembly Set (40-54 cm), Black476D52=SK0452023-12-19
04064406089911Assembly Set (52-62 cm), Black476D52=SK0552023-12-19
04064406089935Clinical Assembly Set (38-42cm), Black476D52=SK0652023-12-19
04064406090221Head Support Mounting Hardware Multi-Crank, Black476L52=SK0152023-12-19
04064406090245Head Support Mounting Hardware Multi-Straigt, Black476L52=SK0252023-12-19
04064406065755"Clamp, 1"", Black"434H1=1-72023-12-19
04064406065779S.T.S. Clamp 3/4 Inch Black434H1=3/4-72023-12-19
04064406065793S.T.S. Clamp 7/8 Inch Black434H1=7/8-72023-12-19
04064406066592Channel Forearm Pad, Large436A2=1-72023-12-19
04064406066608Channel Forearm Pad, Medium436A2=2-72023-12-19
04064406066615Channel Forearm Pad, Small436A2=3-72023-12-19
04064406066622Channel Arm Support One Piece436A3=2-72023-12-19
04064406066752Hand Pad Palm Extenser436P2=L1-72023-12-19
04064406066769Hand Pad Palm Extenser436P2=L2-72023-12-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00761887005402PryorPRYOR PRODUCTSKNO2026-05-31
04034089093246Abduction block (Hercules Prime, Swifty 3Thomas Hilfen für Körperbehinderte GmbH & Co. Medico KommanditgesellschaftKNO2026-05-29
04034089097640crotch pad with magnetic lock (Hercules Prime)Thomas Hilfen für Körperbehinderte GmbH & Co. Medico KommanditgesellschaftKNO2026-05-29
04034089103334Back cushion, seat reducer (Swifty 3)Thomas Hilfen für Körperbehinderte GmbH & Co. Medico KommanditgesellschaftKNO2026-05-29
04034089103341Seat minimizer Swifty 3Thomas Hilfen für Körperbehinderte GmbH & Co. Medico KommanditgesellschaftKNO2026-05-29
04034089103358Seat width reducer Swifty 3Thomas Hilfen für Körperbehinderte GmbH & Co. Medico KommanditgesellschaftKNO2026-05-29
04034089103365Lateral trunk supports, swing-away, Swifty 3Thomas Hilfen für Körperbehinderte GmbH & Co. Medico KommanditgesellschaftKNO2026-05-29
04034089103372Lateral head supports, Swifty 3Thomas Hilfen für Körperbehinderte GmbH & Co. Medico KommanditgesellschaftKNO2026-05-29
04034089103402Frame padding Swifty 3Thomas Hilfen für Körperbehinderte GmbH & Co. Medico KommanditgesellschaftKNO2026-05-29
04034089103419Canopy Swifty 3Thomas Hilfen für Körperbehinderte GmbH & Co. Medico KommanditgesellschaftKNO2026-05-29
04034089103433Rain poncho Swifty 3Thomas Hilfen für Körperbehinderte GmbH & Co. Medico KommanditgesellschaftKNO2026-05-29
04034089103464Pneumatic wheels, set, Swifty 3Thomas Hilfen für Körperbehinderte GmbH & Co. Medico KommanditgesellschaftKNO2026-05-29
04034089103471under seat storage bag Swifty 3Thomas Hilfen für Körperbehinderte GmbH & Co. Medico KommanditgesellschaftKNO2026-05-29
04034089103488under seat storage basket Swifty 3Thomas Hilfen für Körperbehinderte GmbH & Co. Medico KommanditgesellschaftKNO2026-05-29
04034089103495Lateral trunk supports, rigid, Swifty 3Thomas Hilfen für Körperbehinderte GmbH & Co. Medico KommanditgesellschaftKNO2026-05-29
04034089103501Drum brake, set, Swifty 3Thomas Hilfen für Körperbehinderte GmbH & Co. Medico KommanditgesellschaftKNO2026-05-29
04034089103648Chin support rehabThomas Hilfen für Körperbehinderte GmbH & Co. Medico KommanditgesellschaftKNO2026-05-29
04034089104010Incontinence Seat Cover size LThomas Hilfen für Körperbehinderte GmbH & Co. Medico KommanditgesellschaftKNO2026-05-29
00810178884643ViveVIVE HEALTH LLCKNO2026-03-06
00810178884766ViveVIVE HEALTH LLCKNO2026-03-06
00810178884773ViveVIVE HEALTH LLCKNO2026-03-06
00810178884780ViveVIVE HEALTH LLCKNO2026-03-06
00810178884575ViveVIVE HEALTH LLCKNO2025-12-05
00810178884889ViveVIVE HEALTH LLCKNO2025-12-05
00810178884896ViveVIVE HEALTH LLCKNO2025-12-05
00810178884902ViveVIVE HEALTH LLCKNO2025-12-05
00840363373645AxiomKI MOBILITY, LLCKNO2025-12-04
00840363373706AxiomKI MOBILITY, LLCKNO2025-12-04
00840363373874AxiomKI MOBILITY, LLCKNO2025-12-04
00840363374680AxiomKI MOBILITY, LLCKNO2025-12-04