Identity
- Trade Name
- Manual VRA Master Control Box FDA UDI
- Generic Name
- Visual-reinforcement-audiometry reward system FDA UDI
- Model / Reference
- M020201 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817020020389 FDA UDI
- 510(k) Number
- K900096 FDA UDI
- FDA Product Code
- EWO FDA UDI
- GMDN Term
- Visual-reinforcement-audiometry reward system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.1050 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
Category: Visual-reinforcement-audiometry reward system
Manual VRA Master Control Box by Intelligent Hearing Systems Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K900096 also covers:
- Aria — Intelligent Hearing Systems Corp.
- Duet Response Box — Intelligent Hearing Systems Corp.
- External Talk Through Microphone — Intelligent Hearing Systems Corp.
- IntelligentVRA Software — Intelligent Hearing Systems Corp.
- Manual VRA Response Box — Intelligent Hearing Systems Corp.
- SmartAudiometer Software — Intelligent Hearing Systems Corp.
- SoundField USBBox-to-Amp Cable (Mono Plugs) — Intelligent Hearing Systems Corp.
- SoundField USBBox-to-Amp Cable (RCA Plugs) — Intelligent Hearing Systems Corp.
- Toy Cabinet — Intelligent Hearing Systems Corp.
- USB IVRA Master Control Box — Intelligent Hearing Systems Corp.
- USB Response Box — Intelligent Hearing Systems Corp.
- Universal Smart Box — Intelligent Hearing Systems Corp.
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
- Intelligent Hearing Systems Corp.
Sources (1)
- FDA UDI 280230cb-48c2-4d2c-b650-f9a97dc3b014 33 fields · synced Jun 8, 2026