Identity
- Trade Name
- ImPACT Pediatric FDA UDI
- Generic Name
- Cause-and-effect assistive training device FDA UDI
- Device Name
- ImPACT Pediatric is intended for use as a computer-based neurocognitive test battery to aid in the assessment and management of concussion. ImPACT Pediatric is a neurocognitive test battery that provides healthcare professionals with objective measure of neurocognitive functioning as an assessment aid and in the management of concussion in individuals ages 5-11. FDA UDI
- Model / Reference
- ImPACT Pediatric FDA UDI
- Description
- ImPACT Pediatric is intended for use as a computer-based neurocognitive test battery to aid in the assessment and management of concussion. ImPACT Pediatric is a neurocognitive test battery that provides healthcare professionals with objective measure of neurocognitive functioning as an assessment aid and in the management of concussion in individuals ages 5-11. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00864127000318 FDA UDI
- 510(k) Number
- DEN150037 FDA UDI
- FDA Product Code
- POM FDA UDI
- GMDN Term
- Cause-and-effect assistive training device FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1471 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Cause-and-effect assistive training device
ImPACT Pediatric by ImPACT Applications, 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
- ImPACT Applications, Inc.
Sources (1)
- FDA UDI 870edfdd-64dc-4ea7-9119-1299d54c45aa 35 fields · synced Jun 8, 2026