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Positioning Cushion
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 301201Model Head, Neck, and Shoulder Devices
by Medtec LLC
Identity
- Trade Name
- Positioning Cushion FDA UDI
- Generic Name
- Radiological headrest FDA UDI
- Device Name
- Head support (10.2 x 23.1 x 9.7cm) FDA UDI
- Model / Reference
- 301201 EUDAMEDFDA UDIHead, Neck, and Shoulder Devices EUDAMED
- Description
- Head support (10.2 x 23.1 x 9.7cm) FDA UDI
Identifiers
- Catalog Number
- 301201 FDA UDI
- Primary DI / UDI-DI
- 00841439114094 EUDAMEDFDA UDI
- Basic UDI-DI
- 8414391OC0005R01AQ EUDAMED
- 510(k) Number
- K093738 FDA UDI
- FDA Product Code
- LNH FDA UDI
- EMDN Code
- Z12011299 PATIENT POSITIONING INSTRUMENTS – OTHER EUDAMED
- GMDN Term
- Radiological headrest FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1000 FDA UDI
- Market of Registration
- Netherlands 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 Safe FDA UDI
Category: Radiological headrest
Positioning Cushion by Medtec LLC — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Radiological headrest.
- Neck & Brachial Plexus SatPad™ Set — Sat Pad Inc. · Class II
- Nurofit Premiere™ — Qfix · Class I
- Neuro Head Holder — Qfix · Class I
- SCANCOAT — DOMICO MED-DEVICE, LLC · Class I
- SCANCOAT — DOMICO MED-DEVICE, LLC · Class II
- DSA-3Q Head Holder — Qfix · Class I
- DSA-2T Head Holder — Qfix · Class I
- pearltec — Pearl Technology AG · Class I
Cleared under the same submission
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
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 a8469446-4f2d-48a8-9d9c-46f0c2f995e3 36 fields · synced Jul 23, 2026
- EUDAMED 4898ac27-1337-4ebc-b40c-81d516fea88c 61 fields · synced Jul 23, 2026