FDA.reportPublic FDA data

Spex

Primary DI
09420051706255
Brand
Spex
Company
SPEX LIMITED
Model
1275-0043-000
Catalog number
1275-0043-000
Device description
Spex Standard Lateral Head Support Head Support pad
Published
2022-12-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
09420051706255PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09420051706255094200517062559420051706255

GMDN Terms#

Term, Definition table
TermDefinition
Wheelchair/chair/stander headrestA padded device attached to a wheelchair, a disability-supportive chair, and/or a stander to provide a disabled patient with additional head support and comfort while in a sitting and/or standing position. This device will also include the extensions (e.g., a metal insert, screws) needed to attach this device. It may be available in various shapes and sizes, and it may be adjustable.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
6433079790solutions@spexseating.com

Regulatory Flags#

DUNS number
748649195
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09420082689060Spex Seating1255-CUST-0092026-04-30
09420082689077Spex Seating1255-CUST-0522026-04-30
09420082695511Spex Seating1256-CUST-0062026-04-30
09420082699441Spex Seating1259-2850-2002026-04-04
09420082699458Spex Seating1259-2860-2002026-04-04
09420082699434Spex Seating0079-0015-0002026-02-20
09420051799745Spex Seating1102-1010-WSS-F2025-12-12
09420051799752Spex Seating1102-1012-WSS-FI2025-12-12
09420051799769Spex Seating1102-1200-SSF2025-12-12
09420051799776Spex Seating1102-1212-WSS-F2025-12-12
09420051799783Spex Seating1102-1214-WSS-F2025-12-12
09420051799790Spex Seating1102-1216-WSS-F2025-12-12
09420051799820Spex Seating1102-1414-WSS-F2025-12-12
09420051799837Spex Seating1102-1416-WSS-F2025-12-12
09420051799844Spex Seating1102-1418-WSS-F2025-12-12
09420051799738Spex Limited1102-1000-FSS2025-12-05
09420051799806Spex Limited1102-1400-FSS2025-12-05
09420051799813Spex Limited1102-1400-SSF2025-12-05
09420051799851Spex Seating1209-2712-3002025-11-21
09420051706521Spex Limited1156-5822-4102025-11-07

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Primary DI, Brand, Company table
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