Identity
- Trade Name
- K7 ESG-2 Electrosonograph FDA UDI
- Generic Name
- Jaw physiology evaluation system FDA UDI
- Device Name
- TMJ Vibration (Sound) Evaluation System. A lightweight headset holds highly sensitive vibration transducers over each TM joint, enabling simultaneous, bilateral capture of tissue vibrations emanating from joint sounds. Vibration (sound) data is correlated to vertical dimension of opening and closing, providing clinicians with valuable information to aid in assessing the status of articular disk and joint function. FDA UDI
- Model / Reference
- ESG-2 FDA UDI
- Description
- TMJ Vibration (Sound) Evaluation System. A lightweight headset holds highly sensitive vibration transducers over each TM joint, enabling simultaneous, bilateral capture of tissue vibrations emanating from joint sounds. Vibration (sound) data is correlated to vertical dimension of opening and closing, providing clinicians with valuable information to aid in assessing the status of articular disk and joint function. FDA UDI
Identifiers
- Catalog Number
- 0983 FDA UDI
- Primary DI / UDI-DI
- D79209830 FDA UDI
- 510(k) Number
- K970116 FDA UDI
- FDA Product Code
- NFQ FDA UDI
- GMDN Term
- Jaw physiology evaluation system FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.2050 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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Jaw physiology evaluation system
K7 ESG-2 Electrosonograph by Myotronics-Noromed, Inc. — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Myotronics-Noromed, Inc.
Sources (1)
- FDA UDI 10d9097a-b0c2-4a40-a98c-135cf33f2186 35 fields · synced May 31, 2026