Pro Wing Board™

FDA UDI

Class II (US FDA UDI)

by Medtec LLC

Identity

Trade Name: Pro Wing Board™ FDA UDI
Generic Name: Radiological breast positioner, non-wearable FDA UDI
Device Name: Wing Board™ with gel head cup and (2) Pro Handles FDA UDI
Model / Reference: OAP220 FDA UDI
Description: Wing Board™ with gel head cup and (2) Pro Handles FDA UDI

Identifiers

Catalog Number: OAP220 FDA UDI
Primary DI / UDI-DI: 00841439114124 FDA UDI
510(k) Number: K211001 FDA UDI
FDA Product Code: LNH FDA UDI
IYE FDA UDI
GMDN Term: Radiological breast positioner, non-wearable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.1000 FDA UDI
892.5050 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Safe FDA UDI

Category: Radiological breast positioner, non-wearable

Pro Wing Board™ by Medtec LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Radiological breast positioner, non-wearable.

MammoPad Radiolucent Cushion — Hologic, Inc. · Class II
MammoPad Radiolucent Cushion — Hologic, Inc. · Class II
SenoView Prone Breast Board — Aktina Corp. · Class II
MammoPad Radiolucent Cushion — Hologic, Inc. · Class II
Quest™ — Qfix · Class II
Access™ Supine — Qfix · Class II
Breast Riser CX — QUALITY ELECTRODYNAMICS LLC · Class I
ArmCradle4 — Aktina Corp. · Class II

Cleared under the same submission

K211001 also covers:

Evolve Bottom Board — Medtec LLC
Evolve Slant Board — Medtec LLC
Evolve Type-S™ Locating Bar — Medtec LLC
Molded Hand Grip — Medtec LLC
Pro Handle — Medtec LLC

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Medtec LLC

Sources (1)

FDA UDI 3e884f90-14da-457e-a2eb-ef0a93fd8ed5 36 fields · synced May 30, 2026