Prone Thorax Support Cushion

FDA UDI

Class II (US FDA UDI)

by Medtec LLC

Identity

Trade Name: Prone Thorax Support Cushion FDA UDI
Generic Name: Radiological pelvis positioner FDA UDI
Device Name: For use with Belly Board FDA UDI
Model / Reference: 301102 FDA UDI
Description: For use with Belly Board FDA UDI

Identifiers

Catalog Number: 301102 FDA UDI
Primary DI / UDI-DI: 00841439101261 FDA UDI
510(k) Number: K121545 FDA UDI
FDA Product Code: LNH FDA UDI
IYE FDA UDI
GMDN Term: Radiological pelvis positioner 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

Dimensions & Sizes

Size: Width — 15.9 Inch FDA UDI
Length — 14.6 Inch FDA UDI

Category: Radiological pelvis positioner

Prone Thorax Support Cushion by Medtec LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Radiological pelvis positioner.

Qfix® MRI Pelvis System — Qfix · Class II
Back/Abdomen SatPad™ — Sat Pad Inc. · Class II
SofTouch™ — Qfix · Class II
SofTouch™ Elite — Qfix · Class II
MEDRAD® PRO-TEKT Endorectal Balloon — Bayer Medical Care Inc. · Class I
Qfix® Carbon Fiber Pelvis System — Qfix · Class II
Positioning Cushion — Medtec LLC · Class II
HipFix® Baseplate — Medtec LLC · Class II

Cleared under the same submission

K121545 also covers:

Belly Board Flat Cushion — Medtec LLC
Belly Board MRI — 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 c630ce17-fa14-4e3c-8993-0e3a7698e1bc 37 fields · synced Jun 6, 2026