Identity
- Trade Name
- MYOLAB II FDA UDI
- Generic Name
- Biofeedback system FDA UDI
- Device Name
- The Myolab II was specifically designed for use in fitting and troubleshooting the Utah Arm and ProPlus myoelectric prostheses. It can be used to locate muscle activity down to 0.2 microvolts in the remnant limb. The adjustable gain feature allows the device to test and train muscle EMG for any single or dual-channel myoelectric control system. FDA UDI
- Model / Reference
- MC-200 FDA UDI
- Description
- The Myolab II was specifically designed for use in fitting and troubleshooting the Utah Arm and ProPlus myoelectric prostheses. It can be used to locate muscle activity down to 0.2 microvolts in the remnant limb. The adjustable gain feature allows the device to test and train muscle EMG for any single or dual-channel myoelectric control system. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00885859004962 FDA UDI
- FDA Product Code
- HCC FDA UDI
- GMDN Term
- Biofeedback system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5050 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
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: Biofeedback system
Myolab Ii by Motion Control, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Motion Control, Inc.
Sources (1)
- FDA UDI 9e98b82a-2b0d-4296-8be3-6522083c4e60 33 fields · synced May 31, 2026