Identity
- Trade Name
- T.O.V.A. FDA UDI
- Generic Name
- Cognitive assessment software FDA UDI
- Device Name
- The T.O.V.A. microswitch precisely and accurately measures a subject's responses to the Test of Variables of Attention (T.O.V.A.), a computerized assessment of attention and inhibitory control. The T.O.V.A. provides healthcare professionals with objective measurements of attention and inhibitory control. The visual T.O.V.A. aids in the assessment of, and evaluation of treatment for, attention deficits, including attention-deficit/hyperactivity disorder (ADHD). The auditory T.O.V.A. aids in the assessment of attention deficits, including ADHD. T.O.V.A. results should only be interpreted by qualified professionals. FDA UDI
- Model / Reference
- Microswitch FDA UDI
- Description
- The T.O.V.A. microswitch precisely and accurately measures a subject's responses to the Test of Variables of Attention (T.O.V.A.), a computerized assessment of attention and inhibitory control. The T.O.V.A. provides healthcare professionals with objective measurements of attention and inhibitory control. The visual T.O.V.A. aids in the assessment of, and evaluation of treatment for, attention deficits, including attention-deficit/hyperactivity disorder (ADHD). The auditory T.O.V.A. aids in the assessment of attention deficits, including ADHD. T.O.V.A. results should only be interpreted by qualified professionals. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00862290000319 FDA UDI
- 510(k) Number
- K173915 FDA UDI
- FDA Product Code
- LQD FDA UDI
- GMDN Term
- Cognitive assessment software FDA UDI
Classification
- Device Class
- U 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
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Cognitive assessment software
T.o.v.a. by Tova Company, The — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K173915 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 U | Pending data |
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Manufacturer
- Manufacturer
- Tova Company, The
Sources (1)
- FDA UDI 6cb8bfb1-d837-44a8-be51-7385005726e7 35 fields · synced May 31, 2026