Identity
- Trade Name
- MCU Multi-Cervical Unit FDA UDI
- Generic Name
- Neck mechanical weight exerciser FDA UDI
- Device Name
- MCU - Multi Cervical Unit EUDAMEDA rehabilitation device for neck strengthening exercises, as well as measurement of cervical spine range of motion and strength. Neck musculoskeletal measurements can be taken for flexion, extension, lateral flexion, rotation, and for combined planes. FDA UDI
- Model / Reference
- MCU 2 EUDAMEDFDA UDI
- Description
- A rehabilitation device for neck strengthening exercises, as well as measurement of cervical spine range of motion and strength. Neck musculoskeletal measurements can be taken for flexion, extension, lateral flexion, rotation, and for combined planes. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10850390007427 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850390007MultiCervicalGU EUDAMED
- Direct Marketing DI
- 10850390007427 EUDAMED
- FDA Product Code
- IKK FDA UDI
- EMDN Code
- Z120616 ELECTROMECHANICAL SYSTEMS FOR PHYSICAL THERAPY EUDAMED
- GMDN Term
- Neck mechanical weight exerciser FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 890.1925 FDA UDI
- Market of Registration
- Spain EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
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
No
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Neck mechanical weight exerciser
MCU Multi-Cervical Unit by Bte Technologies — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Neck mechanical weight exerciser.
- MedX — MEDX HOLDINGS, INC. · Class II
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 |
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Manufacturer
- Manufacturer
- Bte Technologies
Sources (2)
- FDA UDI 5925ab4b-1df1-4958-8b7f-9a928fa5fc71 35 fields · synced Aug 1, 2026
- EUDAMED bf0c77b0-827e-44cc-b7e5-6e0c43ee1be3 61 fields · synced Aug 1, 2026