FDA.report

Spex Limited

Primary DI
09420082909274
Brand
Spex Limited
Company
SPEX LIMITED
Model
1266-3010-500
Device description
Narrow Straight lateral pad with standard cover including Sunmate overlay, size 0; 85mm high x 115mm deep
Published
2025-03-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
IMSSupport, Head And Trunk, Wheelchair

Product Code Classifications

CodeDeviceSpecialtyClass
IMSSupport, Head And Trunk, WheelchairPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
09420082909274PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
09420082909274094200829092749420082909274

GMDN Terms

TermDefinition
Wheelchair head/trunk support, prefabricatedA prefabricated (non-customized) padded and contoured device designed to attach to the back/seat of a wheelchair to provide the wheelchair occupant with head and trunk postural support and comfort. It may include armrests, a cushioned seat, a belt/harness, thigh support, and/or a tray table. It might additionally be designed for use as a car seat to provide support in vehicles during transportation. This is a reusable device.

Sterilization Methods

Method

Contacts

PhoneEmail
+64330079790solutions@spexseating.com

Regulatory Flags

DUNS number
748649195
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
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 DIBrandModelCatalogPublished
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
09420082600065Spex Limited1102-1414-00C-W2025-05-30
09420082600072Spex Limited1102-1414-0SS-W2025-05-30
09420082600096Spex Limited1102-1414-F0C-W2025-05-31
09420082600133Spex Limited1102-1414-FSS-W2025-05-31
09420082600140Spex Limited1102-1414-SHC2025-05-30
09420082600171Spex Limited1102-1414-THC2025-05-30
09420082600218Spex Limited1102-1416-0SS-W2025-05-30

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