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Apos 4

FDA UDI

Class I (US FDA UDI)

by Apos Medical Assets Ltd

Identity

Trade Name
APOS 4 FDA UDI
Generic Name
Orthotic shoe, custom-made FDA UDI
Model / Reference
APOS 4 BLACK VELCRO HIGH CUT KNOT 49 FDA UDI

Identifiers

Catalog Number
222200149 FDA UDI
Primary DI / UDI-DI
07290019388425 FDA UDI
510(k) Number
K182090 FDA UDI
FDA Product Code
QDT FDA UDI
GMDN Term
Orthotic shoe, custom-made FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
890.3475 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

Yes

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Orthotic shoe, custom-made

Apos 4 by Apos Medical Assets Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthotic shoe, custom-made.

Cleared under the same submission

K182090 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Apos Medical Assets Ltd

Sources (1)

  • FDA UDI 834334d3-c9dc-4581-addf-26d67fb40faf 34 fields · synced May 31, 2026