Pap-Ion Magnetic Inductor: Difference between revisions
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'''Pap-Ion Magnetic Inductor''' ('''PAP-IMI''' or '''Papimi''') is an electromagnetic "[[energy medicine]]" device manufactured in Greece. It is illegal for use in the United States due to lack of [[Food and Drug Administration|FDA]] approval.<ref name="snakeoil">{{cite web |url=http://seattletimes.nwsource.com/html/medicaldevices/ |date=December 26, 2008 |work=[[Seattle Times]] |title=Miracle Machines: The 21st-Century Snake Oil}}</ref><ref>[http://seattletimes.nwsource.com/html/localnews/2004022169_miraclegolob19m0.html Risky devices found in Issaquah, Bellevue], [[Seattle Times]], 19 November 2007</ref> [[Jay Inslee]] of the House [[United States House Energy Subcommittee on Oversight and Investigations|Energy Subcommittee on Oversight and Investigations]] states that it "claims to pulse the body with electromagnetic waves, has been marketed as a rapid-healing machine to patients suffering cancer, AIDS, chronic fatigue and allergies, among other health problems." The device is described as "potentially dangerous".<ref>[http://www.house.gov/apps/list/press/wa01_inslee/medicaldevices.shtml Letter from rep. Jay Inslee] (House Energy and Commerce Subcommittee on Oversight and Investigations), 20 November 2007.</ref> [[Health Canada]] |
'''Pap-Ion Magnetic Inductor''' ('''PAP-IMI''' or '''Papimi''') is an electromagnetic "[[energy medicine]]" device manufactured in Greece. It is illegal for use in the United States due to lack of [[Food and Drug Administration|FDA]] approval.<ref name="snakeoil">{{cite web |url=http://seattletimes.nwsource.com/html/medicaldevices/ |date=December 26, 2008 |work=[[Seattle Times]] |title=Miracle Machines: The 21st-Century Snake Oil}}</ref><ref>[http://seattletimes.nwsource.com/html/localnews/2004022169_miraclegolob19m0.html Risky devices found in Issaquah, Bellevue], [[Seattle Times]], 19 November 2007</ref> [[Jay Inslee]] of the House [[United States House Energy Subcommittee on Oversight and Investigations|Energy Subcommittee on Oversight and Investigations]] states that it "claims to pulse the body with electromagnetic waves, has been marketed as a rapid-healing machine to patients suffering cancer, AIDS, chronic fatigue and allergies, among other health problems." The device is described as "potentially dangerous".<ref>[http://www.house.gov/apps/list/press/wa01_inslee/medicaldevices.shtml Letter from rep. Jay Inslee] (House Energy and Commerce Subcommittee on Oversight and Investigations), 20 November 2007.</ref> [[Health Canada]] had issued a recommendation for the public to avoid use of these risky, unlicensed devices, and had ordered the [[Canada Border Services Agency]] to seize them upon attempted import into the country.<ref>[http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2007/2007_178-eng.php Use of Unlicensed Pap-Ion Magnetic Inductor May Pose Health Risk], 28 December, 2007.</ref> However, now the device is properly licensed by Health Canada<ref>[http://webprod5.hc-sc.gc.ca/mdll-limh/prepareSearch-preparerRecherche.do?type=active&lang=eng Health Canada Licence listing] , Licence No.: 81519</ref> |
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Actor [[Dan Haggerty]] has appeared in commercial endorsements for the device, although there is no evidence he was aware of the legal and ethical problems associated with it at the time he agreed to endorse it.<ref name="snakeoil"/> |
Actor [[Dan Haggerty]] has appeared in commercial endorsements for the device, although there is no evidence he was aware of the legal and ethical problems associated with it at the time he agreed to endorse it.<ref name="snakeoil"/> |
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Although importation of the device to the US is illegal, a number of machines were imported under fraudulent descriptions.<ref>{{cite news|url=http://www.sunjournal.com/node/101645|title=Federal agency bans import of fugitive's 'miracle machines'|date=9 December 2007|work=[[Sun Journal]]|location=Seattle}}</ref><ref>[http://www.casewatch.org/ag/ca/papimi/complaint.shtml California Court Bans Unubstantiated Claims for Pap-IMI Device]</ref> |
Although importation of the device to the US is illegal, a number of machines were imported under fraudulent descriptions.<ref>{{cite news|url=http://www.sunjournal.com/node/101645|title=Federal agency bans import of fugitive's 'miracle machines'|date=9 December 2007|work=[[Sun Journal]]|location=Seattle}}</ref><ref>[http://www.casewatch.org/ag/ca/papimi/complaint.shtml California Court Bans Unubstantiated Claims for Pap-IMI Device]</ref> |
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Pap-imi<sup>TM</sup> device has been tested and successfully passed every trial required by the European standards and laws, and has been certified with CE medical (CE0044) by the notified bodies HEEQAC S.A. Moreover the manufacturer is certified for ISO9001:2008, ISO13485:2003 + AC2007 and CAN/CSA ISO13485:2003, and certified for<ref>[http://www.papimi.com/WEBSITE%20PICS/HEEQUACKeng.jpg Laboratory Test Report]{{Primary source-inline|date=September 2011}}</ref><ref>[http://heeqac.gr/ Test Laboratory official website]</ref> and TUEV Nord Cert GmbH ([[TÜV]]). conformity to the European directive MDD93/42/EEC regarding the manufacturing of medical devices. |
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The manufacturer of the Pap-ion Magnetic Inductor asserts the device is safe and effective, listing private case studies and official clinical studies on its website.<ref>[https://www.ncbi.nlm.nih.gov/pubmed/21537858 Benign Prostate Hyperplasia study]</ref> |
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<ref>[https://www.ncbi.nlm.nih.gov/pubmed/17486634 Wound Healing study]</ref><ref>[https://www.ncbi.nlm.nih.gov/pubmed/7531030 Pelvic pain study]</ref> |
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==References== |
==References== |
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Revision as of 00:16, 16 April 2014
Pap-Ion Magnetic Inductor (PAP-IMI or Papimi) is an electromagnetic "energy medicine" device manufactured in Greece. It is illegal for use in the United States due to lack of FDA approval.[1][2] Jay Inslee of the House Energy Subcommittee on Oversight and Investigations states that it "claims to pulse the body with electromagnetic waves, has been marketed as a rapid-healing machine to patients suffering cancer, AIDS, chronic fatigue and allergies, among other health problems." The device is described as "potentially dangerous".[3] Health Canada had issued a recommendation for the public to avoid use of these risky, unlicensed devices, and had ordered the Canada Border Services Agency to seize them upon attempted import into the country.[4] However, now the device is properly licensed by Health Canada[5]
Actor Dan Haggerty has appeared in commercial endorsements for the device, although there is no evidence he was aware of the legal and ethical problems associated with it at the time he agreed to endorse it.[1]
Although importation of the device to the US is illegal, a number of machines were imported under fraudulent descriptions.[6][7]
Pap-imiTM device has been tested and successfully passed every trial required by the European standards and laws, and has been certified with CE medical (CE0044) by the notified bodies HEEQAC S.A. Moreover the manufacturer is certified for ISO9001:2008, ISO13485:2003 + AC2007 and CAN/CSA ISO13485:2003, and certified for[8][9] and TUEV Nord Cert GmbH (TÜV). conformity to the European directive MDD93/42/EEC regarding the manufacturing of medical devices.
The manufacturer of the Pap-ion Magnetic Inductor asserts the device is safe and effective, listing private case studies and official clinical studies on its website.[10] [11][12]
References
- ^ a b "Miracle Machines: The 21st-Century Snake Oil". Seattle Times. December 26, 2008.
- ^ Risky devices found in Issaquah, Bellevue, Seattle Times, 19 November 2007
- ^ Letter from rep. Jay Inslee (House Energy and Commerce Subcommittee on Oversight and Investigations), 20 November 2007.
- ^ Use of Unlicensed Pap-Ion Magnetic Inductor May Pose Health Risk, 28 December, 2007.
- ^ Health Canada Licence listing , Licence No.: 81519
- ^ "Federal agency bans import of fugitive's 'miracle machines'". Sun Journal. Seattle. 9 December 2007.
- ^ California Court Bans Unubstantiated Claims for Pap-IMI Device
- ^ Laboratory Test Report[non-primary source needed]
- ^ Test Laboratory official website
- ^ Benign Prostate Hyperplasia study
- ^ Wound Healing study
- ^ Pelvic pain study
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