MANDELAY KFT · 89-08 · HUNGARY
For MANDELAY KFT, import alert is 89-08; country is HUNGARY; import alert name is "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"; product is The Quantum Xrroid Consciousness/Medical Interface System Unclassified; product code is 84 - - - -- Neurological | 84 H - - CC Device, Biofeedback; date published is 01/23/2019; address is Huba Utca 25-2 , Tokol, Pest HUNGARY, verified against its source on 2026-09-30.
- Firm
- MANDELAY KFT verified
- Import alert
- 89-08
- Import alert name
- "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"
- Country
- HUNGARY verified
- Address
- Huba Utca 25-2 , Tokol, Pest HUNGARY verified
- Date published
- 01/23/2019 verified
- Product code
- 84 - - - -- Neurological | 84 H - - CC Device, Biofeedback each item verified
- Product
- The Quantum Xrroid Consciousness/Medical Interface System Unclassified verified
- FDA notes
- 6/28/2002 | Electro Physiological Feedback Xrroid (EPFX) Quantum Xrroid (QXCl) QXCl Accessories Scientific Conscionesssness Interface Operations System (SCIO) Virtual Reality Imagery; Ascultacardiogram; CLASP 32 Master Program 1 CD; CLASP 32 Master Program 2 CD; Living Information Forms Energy L.I.F.E System 1/4/2008. each item verified
What the source says
MANDELAY KFT Date Published : 01/23/2019 Huba Utca 25-2 , Tokol, Pest HUNGARY
— accessdata.fda.gov, retrieved 2026-09-22
Where each value comes from
The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.
Product code, Product and FDA notes
84 - - - -- Neurological Date Published: 01/23/2019 Desc: The Quantum Xrroid Consciousness/Medical Interface System Unclassified Notes: 6/28/2002 84 H - - CC Device, Biofeedback Date Published: 05/06/2021 Notes: Electro Physiological Feedback Xrroid (EPFX) Quantum Xrroid (QXCl) QXCl Accessories Scientific Conscionesssness Interface Operations System (SCIO) Virtual Reality Imagery; Ascultacardiogram; CLASP 32 Master Program 1 CD; CLASP 32 Master Program 2 CD; Living Information Forms Energy L.I.F.E System 1/4/2008.
— all from accessdata.fda.gov, retrieved 2026-09-22
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html