← Back to catalogue
Feetfix™ MR Platform
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 302071MRModel Breast and Pelvis
by Medtec LLC
Identity
- Trade Name
- Feetfix™ MR Platform FDA UDI
- Generic Name
- Radiological arm/leg positioner FDA UDI
- Device Name
- Feetfix™ MR Platform FDA UDI
- Model / Reference
- 302071MR EUDAMEDFDA UDIBreast and Pelvis EUDAMED
- Description
- Feetfix™ MR Platform FDA UDI
Identifiers
- Catalog Number
- 302071MR FDA UDI
- Primary DI / UDI-DI
- 00841439111918 EUDAMEDFDA UDI
- Basic UDI-DI
- 8419621BREASTPELVISTG EUDAMED
- FDA Product Code
- LNH FDA UDIIYE FDA UDI
- EMDN Code
- Z12011280 PATIENT POSITIONING INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Radiological arm/leg positioner FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1000 FDA UDI892.5050 FDA UDI
- Market of Registration
- Malta EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
MR Conditional FDA UDI
Category: Radiological arm/leg positioner
Feetfix™ MR Platform by Medtec LLC — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Radiological arm/leg positioner.
- Intelli-C Accessory — Nrt - Nordisk Røntgen Teknik A/S · Class II
- Intelli-C Accessory — Nrt - Nordisk Røntgen Teknik A/S · Class II
- SCANCOAT — DOMICO MED-DEVICE, LLC · Class II
- Elevate ArmBoard - Right Hand — Semler Technologies, Inc. · Class I
- Scancoat — DOMICO MED-DEVICE, LLC · Class II
- SCANCOAT — DOMICO MED-DEVICE, LLC · Class II
- Scancoat — DOMICO MED-DEVICE, LLC · Class II
- Ankle/Foot SatPad™ — Sat Pad Inc. · 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
K093738 also covers:
- AccuForm™ Cushion — Medtec LLC
- Headrest - TIMO Size A, B, C, F — Medtec LLC
- Headrest - Timo size F with base — Medtec LLC
- HipFix® Thermoplastic — Medtec LLC
- HipFix® Thermoplastic — Medtec LLC
- MR Posi-S™ Adapter — Medtec LLC
- Monarch™ Overhead Arm Positioner — Medtec LLC
- Posicast® Thermoplastic — Medtec LLC
- Posicast® Thermoplastic — Medtec LLC
- Posicast® Thermoplastic — Medtec LLC
- Posicast® Thermoplastic — Medtec LLC
- Posifix® Headrest — Medtec LLC
K180021 also covers:
- AccuForm™ Cushion — Medtec LLC
- AccuForm™ Cushion — Medtec LLC
- AccuForm™ Cushion — Medtec LLC
- Patient Hand Grip — Medtec LLC
- Pediatric Cushion Guide — Medtec LLC
- Pediatric Registration Film — Medtec LLC
- Positioning Cushion — Medtec LLC
- ProForm™ Pediatric Thermoplastic — Medtec LLC
- ProForm™ Thermoplastic — Medtec LLC
- ProForm™ Thermoplastic — Medtec LLC
- ProForm™ Thermoplastic — Medtec LLC
- ProForm™ Thermoplastic — Medtec LLC
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| 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 (2)
- FDA UDI 2500e59e-6c11-4e57-8598-4bb7b9d9d2c3 36 fields · synced Jun 19, 2026
- EUDAMED 8a387fd3-8468-4ee9-99ad-a48502bec9ee 61 fields · synced Jun 19, 2026