FDA accessdata (Import Alert 89-08) and CIRCARE (FDA warning-letter archive), 2026-10-04 (Investigator run 1)

Query (Google, in Chrome): "PAP-IMI" FDA "import alert" OR "warning letter" OR IDE. The same results page listed MDDI (1 Feb 2008, "CDRH Promises Crackdown on Risky Devices"), the Seattle Times (30 Jan 2008, "Fraudulent medical devices targeted"; 4 Jan 2008, "State urges FDA to ban unproven medical devices"), Herald Extra (8 Dec 2007, "FDA bans import of 'miracle machines'"), an Ovid "Biomedical Safety & Standards" item (15 Feb 2008), a Chronicle of Higher Education blog on the TABS IRB, and a Yumpu document "Cases from private practices - Papimi" (inventor-side case collection). None of these was opened this run.

FDA Import Alert 89-08 [web] https://www.accessdata.fda.gov/cms_ia/importalert_244.html

Saved: research/files/fda-importalert-89-08.html - Entry under GREECE: "BioElectroDynamics, Date Published: 12/20/2018, no known street address, Athens, GREECE. 84 - - - -- Neurological... Desc: PAP-IMI Ion Magnetic Conductor Device Notes: Unclassified". - Entry under UNITED STATES: "Bio-Energy Services Inc. Date Published: 09/16/2009, 18727 Ventura Blvd, Tarzana, CA 91356-3302... Notes: Importer of Record for PAP-IMI Ion Magnetic Conductor Device Unclassified Industry Code 84. 1/13/2003". - The import alert is a regulator's action (interested party). It records that US entry of the device is subject to detention without physical examination. The Greek maker's name ("BioElectroDynamics") matches the R&D company in the 2002 EIR.

FDA Warning Letter, 24 Jun 2003, to Cheryl Jones Jaye MD, LifeWorks Wellness Center, Clearwater FL [web] http://www.circare.org/fdawls3/jonesjaye_20030624.pdf

Saved: research/files/circare-FDA-WL-jonesjaye-20030624.pdf (text layer present). - Inspection 19-28 Mar 2003 (FDA Florida District). The device name is redacted in the released letter. CIRCARE's index labels the letter "[PAP-IMI]", and the Seattle Times names LifeWorks as a PAP-IMI site; the device identification therefore rests on those two sources. - Findings: treatment outside the study (including the investigator and a coordinator); at least 6 subjects without consent documents; at least 5 treated before consent; "Your Center treated at least 50 subjects during the time the study lacked IRB approval" (IRB approval only from 24 Sep 2002); 5 of 29 files did not meet inclusion/exclusion criteria.

How this bears on the claims

• These are regulatory and process records; they do not test the physics (claims 1-4). For claim 5 they document that the US "clinical study" of 2001-2005 did not produce usable controlled data, according to the regulator.