FDA.report

Spex Limited

Primary DI
09420051745575
Brand
Spex Limited
Company
SPEX LIMITED
Model
1259-2200-100
Device description
Spex Back Support Dual Mount Hardware
Published
2025-02-21
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

Product Codes

CodeName
KNNComponents, Wheelchair

Product Code Classifications

CodeDeviceSpecialtyClass
KNNComponents, WheelchairPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
09420051745575PrimaryGS10

GMDN Terms

TermDefinition
Wheelchair back restA padded support (typically vinyl covered) designed to attach to the back of a wheelchair. It typically replaces the wheelchair's sling upholstery and provides the wheelchair occupant with improved back support, posture, air circulation, and comfort.

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
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 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

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
09420082699434Spex SeatingSPEX LIMITEDKNN2026-02-20
00841447116424The Aftermarket Group (TAG) Schwalbe Right Run Wheelchair TireINVACARE CORPORATIONKNN2026-02-05
05407008321246mo-vismo-VisKNN2026-01-01
00815067013548ProbasicsCOMPASS HEALTH BRANDS CORP.KNN2025-08-13
00815067013555ProbasicsCOMPASS HEALTH BRANDS CORP.KNN2025-08-13
00815067013562ProbasicsCOMPASS HEALTH BRANDS CORP.KNN2025-08-13
00815067013579ProbasicsCOMPASS HEALTH BRANDS CORP.KNN2025-08-13
04714379299328MERITSMERITS HEALTH PRODUCTS CO., LTD.KNN2025-08-08
04714379299335MERITSMERITS HEALTH PRODUCTS CO., LTD.KNN2025-08-08
04714379299342MERITSMERITS HEALTH PRODUCTS CO., LTD.KNN2025-08-08
04714379299359MERITSMERITS HEALTH PRODUCTS CO., LTD.KNN2025-08-08
10197344158393MEDLINEMEDLINE INDUSTRIES, INC.KNN2025-07-28
00815067013074ProbasicsCOMPASS HEALTH BRANDS CORP.KNN2025-07-21
00815067013081ProbasicsCOMPASS HEALTH BRANDS CORP.KNN2025-07-21
10197344155279MEDLINEMEDLINE INDUSTRIES, INC.KNN2025-06-27
05407008321130mo-Vismo-VisKNN2025-03-27
05407008321147mo-Vismo-VisKNN2025-03-27
05407008321154mo-Vismo-VisKNN2025-03-27
05407008321161mo-Vismo-VisKNN2025-03-27
05407008321178mo-Vismo-VisKNN2025-03-27
05407008321185mo-Vismo-VisKNN2025-03-27
05407008321116mo-vismo-VisKNN2025-03-21
05407008321192mo-Vismo-VisKNN2025-03-21
05407008321208mo-vismo-VisKNN2025-03-21
05407008321215mo-vismo-VisKNN2025-03-21
09420051706217Spex LimitedSPEX LIMITEDKNN2025-03-18
09420051706798Spex LimitedSPEX LIMITEDKNN2025-03-18
09420051709881Spex LimitedSPEX LIMITEDKNN2025-03-18
09420051709911Spex LimitedSPEX LIMITEDKNN2025-03-18
09420051709935Spex LimitedSPEX LIMITEDKNN2025-03-18