Identity
- Trade Name
- Positioning Cushion FDA UDI
- Generic Name
- Radiological pelvis positioner FDA UDI
- Device Name
- Prone thorax support FDA UDI
- Model / Reference
- 301076 FDA UDI
- Description
- Prone thorax support FDA UDI
Identifiers
- Catalog Number
- 301076 FDA UDI
- Primary DI / UDI-DI
- 00841439101148 FDA UDI
- 510(k) Number
- K060737 FDA UDI
- FDA Product Code
- IYE FDA UDI
- GMDN Term
- Radiological pelvis positioner FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.5050 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
Dimensions & Sizes
- Size
- Width — 37.1 Centimeter FDA UDILength — 40.3 Centimeter FDA UDI
Category: Radiological pelvis positioner
Positioning 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
- HipFix® Baseplate — Medtec LLC · Class II
- Belly Board MRI — Medtec LLC · Class II
Cleared under the same submission
K060737 also covers:
- Arm Support — Medtec LLC
- Arm Support — Medtec LLC
- Arm Support — Medtec LLC
- Immobilizer — Medtec LLC
- MR Posi-S™ Adapter — Medtec LLC
- Posicast® Thermoplastic — Medtec LLC
- Posicast® Thermoplastic — Medtec LLC
- Posicast® Thermoplastic — Medtec LLC
- Posicast® Thermoplastic — Medtec LLC
- Posifix® -2 Baseplate — Medtec LLC
- Posifix® Headrest — Medtec LLC
- Posifix® Headrest — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medtec LLC
Sources (1)
- FDA UDI d463f7dd-2ab9-4cb6-91bc-8d76a905be75 37 fields · synced May 30, 2026