Intelligent Hearing Systems Corp.
Miami, FL, US
INTELLIGENT HEARING SYSTEMS CORP. appears in FDA device records in Miami, FL. FDA records list 13 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 13 510(k) clearances for Intelligent Hearing Systems Corp. between 1991 and 2017. The busiest year on record is 2006, with 2. The most recent is 2017, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1991 | 1 |
| 1992 | 1 |
| 1993 | 1 |
| 1997 | 1 |
| 2003 | 1 |
| 2004 | 1 |
| 2005 | 1 |
| 2006 | 2 |
| 2007 | 1 |
| 2008 | 1 |
| 2009 | 1 |
| 2017 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K163326 | SmartEP | GWJ | Substantially Equivalent | |
| K090579 | SMARTSCREENER-PLUS2 | GWJ | Substantially Equivalent | |
| K073384 | SMART COUPLER, MODEL M015401 | GWJ | Substantially Equivalent | |
| K070608 | SMARTEP, MODEL M010000 | GWJ | Substantially Equivalent | |
| K063402 | WICK ELECTRODE, MODEL M019260 | GXY | Substantially Equivalent | |
| K061443 | SMART USBLITE, MODEL M011120 | GWJ | Substantially Equivalent | |
| K052060 | OPTI-AMP DC-POWERED | GWL | Substantially Equivalent | |
| K031051 | SMARTEP-ASSR, MODEL M811007 | GWJ | Substantially Equivalent | |
| K023859 | SMARTTROAE | EWO | Substantially Equivalent | |
| K964426 | SMARTOAE | EWO | Substantially Equivalent | |
| K925648 | SMART-SCREENER (AUDITORY) | GWJ | Substantially Equivalent | |
| K914876 | OPTI-AMP | GWL | Substantially Equivalent | |
| K904926 | SMART-EP | GWJ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1052723 | 1000113738 | INTELLIGENT HEARING SYSTEMS CORP. | 6860 Sw 81st St, MIAMI, FL 33143 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1704-2010 | Intelligent Hearing Systems Corporation, SmartEP with Vestibular Evoked Myogenic Potentials Version 3.96. Model M811016 | This was a marketing correction mandated by the United States Food and Drug Administration (USFDA). USFDA notified Intelligent Hearing Systems that 501(k) premarket notification application must be submitted and cleared in order to market and sell devices with Vestibular Evoked Myogenic Potential (VEMP) specific functions. The Food and Drug Administration considers that the VEMP testing functions | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain