Identity
- Trade Name
- BioJVA FDA UDI
- Generic Name
- Jaw physiology evaluation system FDA UDI
- Device Name
- Indications for use: 2 channel JVA amplifier 1. To record and display sounds/vibrations from the temporomandibular joints. 2. To aid the clinician in their analysis of a joint sound/vibration by allowing them to see the waveform in various standard plots. 3. To aid the clinician in comparing a patient's current stand plots to previous recordings before, during, and after treatment. 4. To provide numerical values that can be used to quantify the physical characteristics of the sounds/vibrations, allowing intra-patient comparisons (only) by the clinician. FDA UDI
- Model / Reference
- Amplifier USB-231 FDA UDI
- Description
- Indications for use: 2 channel JVA amplifier 1. To record and display sounds/vibrations from the temporomandibular joints. 2. To aid the clinician in their analysis of a joint sound/vibration by allowing them to see the waveform in various standard plots. 3. To aid the clinician in comparing a patient's current stand plots to previous recordings before, during, and after treatment. 4. To provide numerical values that can be used to quantify the physical characteristics of the sounds/vibrations, allowing intra-patient comparisons (only) by the clinician. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860009598218 FDA UDI
- 510(k) Number
- K905657 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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Jaw physiology evaluation system
BioJVA by Bio-Research Associates, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K905657 also covers:
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
- Bio-Research Associates, Inc.
Sources (1)
- FDA UDI e631b2b4-4839-46d8-976d-a51245b43c3b 35 fields · synced May 29, 2026