Recall Z-2730-2015— Neuro Kinetics, Inc.
Class II · Terminated
Class II FDA medical device recall by Neuro Kinetics, Inc., initiated 2015-07-21, terminated 2016-09-27. It names 2 FDA 510(k) clearances: K143607, K083603. Product: Neuro Kinetics, Inc. (NKI) I-Portal¿ NOTC system with the OVAR research test; a rotary chair system used in vestibular and neuro-otologic diagnostic testing. This device provides no diagnoses nor does it provide diagnostic recommendations.The OVAR test has not yet been cleared by the FDA, and until then can only be used as an investigational device.. Reason: The devices that included the OVAR research test were not cleared for marketing and mTBI research package was sold with the incorrect investigational label..
- Recalling firm
- Neuro Kinetics, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-07-21
- Terminated
- 2016-09-27
- Firm location
- Pittsburgh, PA, United States
510(k) clearances named in this recall
2 on FDA's record- K143607 — I-Portal NOTC, VNG and VOG
- K083603 — I-PORTAL 4D VIDEO OCULOGRAPHY EYE TRACKING SYSTEM (VOG), I-PORTAL VIDEO NYSTAGMOGRAPHY SYSTEM (VNG), I-PORTAL NEURO OTOL
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Neuro Kinetics, Inc. (NKI) I-Portal¿ NOTC system with the OVAR research test; a rotary chair system used in vestibular and neuro-otologic diagnostic testing. This device provides no diagnoses nor does it provide diagnostic recommendations.The OVAR test has not yet been cleared by the FDA, and until then can only be used as an investigational device.
Reason for recall
The devices that included the OVAR research test were not cleared for marketing and mTBI research package was sold with the incorrect investigational label.
Data sourced from openFDA. This site is unofficial and independent of the FDA.