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Sign in to claim this brandIntelligent Hearing Systems Corp.
United States·US-MF-000011473
Last updated September 17, 2026
Information
- Country
- United States
- Address
- 6860 SW 81st Street, Miami, United States
- Website
- ihsys.com
- —
- —
- [email protected]
- Phone
- —
- PRRC Contact
- Edward Miskiel
- EUDAMED SRN
- US-MF-000011473
- FDA FEI Number
- 1000113738
- DUNS Number
- —
Catalogue (101)
Page 3 of 3| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| USB Jr Duet | M010300 | EUDAMEDFDA UDI | Class IIa | Active |
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FDA Recalls (1)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Oct 21, 2008 | Z-1704-2010 | — | terminated | 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 |