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Spex

FDA UDI

Class I (US FDA UDI)

by Spex Limited

Identity

Trade Name
Spex FDA UDI
Generic Name
Wheelchair/chair/stander occupant restraint/support FDA UDI
Device Name
Footfast Ankle Stabilisers Size Medium with Retainer Strap (Pair) FDA UDI
Model / Reference
1401-6166-017 FDA UDI
Description
Footfast Ankle Stabilisers Size Medium with Retainer Strap (Pair) FDA UDI

Identifiers

Catalog Number
1401-6166-017 FDA UDI
Primary DI / UDI-DI
09420051701267 FDA UDI
FDA Product Code
KNO FDA UDI
GMDN Term
Wheelchair/chair/stander occupant restraint/support FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
890.3910 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Wheelchair/chair/stander occupant restraint/support

Spex by Spex Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Wheelchair/chair/stander occupant restraint/support.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Spex Limited

Sources (1)

  • FDA UDI 99f7a513-2b10-4d78-88c9-4381b37932f4 35 fields · synced May 30, 2026