FDA.report

Spex

Primary DI
09420051707580
Brand
Spex
Company
SPEX LIMITED
Model
1406-6412-026
Catalog number
1406-6412-026
Device description
Spex Padded 4-point hip belt - centre pull with anti-escape buckle Medium
Published
2022-12-12
Public version status
Update
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
FMQRestraint, Protective
KNOAccessories, Wheelchair

Product Code Classifications

CodeDeviceSpecialtyClass
FMQRestraint, ProtectiveGeneral Hospital1
KNOAccessories, WheelchairPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
09420051707580PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
09420051707580094200517075809420051707580

GMDN Terms

TermDefinition
Wheelchair/chair/stander occupant restraint/supportA rigid or non-rigid device, typically a strap, belt, bar, harness or vest designed to be attached to a wheelchair/chair/stander and/or its occupant to stabilize the occupant’s position for prevention of slips and/or falls from the appliance and/or to provide postural support. Some types may also be used to secure a wheelchair occupant in a wheelchair while travelling in a motor vehicle. This device may also include the extensions needed to attach this device and may be available in various sizes.

Sterilization Methods

Method

Contacts

PhoneEmail
6433079790solutions@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
00810178884643ViveVIVE HEALTH LLCKNO2026-03-06
00810178884766ViveVIVE HEALTH LLCKNO2026-03-06
00810178884773ViveVIVE HEALTH LLCKNO2026-03-06
00810178884780ViveVIVE HEALTH LLCKNO2026-03-06
00840363371429AxiomKI MOBILITY, LLCKNO2025-12-05
00840363371528AxiomKI MOBILITY, LLCKNO2025-12-05
00840363371603AxiomKI MOBILITY, LLCKNO2025-12-05
00840363371627AxiomKI MOBILITY, LLCKNO2025-12-05
00840363371702AxiomKI MOBILITY, LLCKNO2025-12-05
00840363371764AxiomKI MOBILITY, LLCKNO2025-12-05
00840363371795AxiomKI MOBILITY, LLCKNO2025-12-05
00840363373645AxiomKI MOBILITY, LLCKNO2025-12-04
00840363373706AxiomKI MOBILITY, LLCKNO2025-12-04
00840363373874AxiomKI MOBILITY, LLCKNO2025-12-04
00840363374680AxiomKI MOBILITY, LLCKNO2025-12-04
00840363374796AxiomKI MOBILITY, LLCKNO2025-12-04
00840363374871AxiomKI MOBILITY, LLCKNO2025-12-04
00840363375144AxiomKI MOBILITY, LLCKNO2025-12-04
00840363375441AxiomKI MOBILITY, LLCKNO2025-12-04
00840363369631AxiomKI MOBILITY, LLCKNO2025-12-02
00840363369693AxiomKI MOBILITY, LLCKNO2025-12-02
00840363370446AxiomKI MOBILITY, LLCKNO2025-12-02
00840363370545AxiomKI MOBILITY, LLCKNO2025-12-02
00840363370651AxiomKI MOBILITY, LLCKNO2025-12-02
00840363370811AxiomKI MOBILITY, LLCKNO2025-12-02
00840363371047AxiomKI MOBILITY, LLCKNO2025-12-02
00840363371054AxiomKI MOBILITY, LLCKNO2025-12-02
00840363371160AxiomKI MOBILITY, LLCKNO2025-12-02
00840363371337AxiomKI MOBILITY, LLCKNO2025-12-02
00840363369617AxiomKI MOBILITY, LLCKNO2025-12-02