Import Alert 87-01
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(Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or products(s) at issue. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public).
Import Alert # 87-01
Published Date: 03/18/2011
Type: DWPE
Import Alert Name:
"Detention Without Physical Examination Of Magnetic Support Devices Lacking Premarket Approval"
Reason for Alert:
Buffalo district investigated a mail order forwarder for Magnetic Health Products, identified as Gloria Aubrey, 75 State Street, Rouses Point, New York, as a follow up to a consumer complaint. Gloria Aubrey was found to be an unregistered initial distributor of imported magnetic support devices. These devices are promoted by Magnetic Health Products, a Canadian firm, in tabloid type newspapers for the relief of back, knee, and elbow pain. The product is an elasticized band with magnets sewn in place and a velcro closure.
The district investigation further revealed that magnetic support devices have been imported by Magnetic Health Products, Globe Health Products, and Gloria Aubrey, 75 State Street, Rouses Point, New York 12979. The parent firm for Magnetic Health Products is Marathon Health Products, 2165 Vincent Street, Saint Laurent, Quebec, Canada. The foreign manufacturer identified by Magnetic Health Products is Lih Hwa Industrial Company, Ltd., Taipei, Taiwan. Shippers/manufacturers identified from entry documents include Taiwan Daido, Ltd. of Taipei, Taiwan and Harter Corporation of Taipei, Taiwan.
Consumer orders for magnetic support devices are processed by Magnetic Health Products via a Rouses Point, New York post office box. The orders are filled and mailed to customers by Gloria Aubrey, Rouses Point, New York as directed by the Canadian firm.
We also have information that imported knee and elbow supports have been invoiced as magnetic acupuncture products under other entries. According to one entry labeled as a "Port a Paedic" support for Shelbud Products Corporation, New Rochelle, New York, the device was ordered through a Rouses Point, New York mailbox and mailed from Gloria Aubrey, Rouses Point, New York to the distributor.
CDRH has reviewed a 510(k) notification received from Magnetic Health Products and determined that magnetic support devices are class III devices under section 513(f) of the Federal Food, Drug, and Cosmetic Act. Section 515(a)(2) of the Act requires class III devices to have an approved premarket approval (PMA) application before they can be legally marketed in the U.S. No PMA has been approved for these magnetic support devices
The district investigation further revealed that magnetic support devices have been imported by Magnetic Health Products, Globe Health Products, and Gloria Aubrey, 75 State Street, Rouses Point, New York 12979. The parent firm for Magnetic Health Products is Marathon Health Products, 2165 Vincent Street, Saint Laurent, Quebec, Canada. The foreign manufacturer identified by Magnetic Health Products is Lih Hwa Industrial Company, Ltd., Taipei, Taiwan. Shippers/manufacturers identified from entry documents include Taiwan Daido, Ltd. of Taipei, Taiwan and Harter Corporation of Taipei, Taiwan.
Consumer orders for magnetic support devices are processed by Magnetic Health Products via a Rouses Point, New York post office box. The orders are filled and mailed to customers by Gloria Aubrey, Rouses Point, New York as directed by the Canadian firm.
We also have information that imported knee and elbow supports have been invoiced as magnetic acupuncture products under other entries. According to one entry labeled as a "Port a Paedic" support for Shelbud Products Corporation, New Rochelle, New York, the device was ordered through a Rouses Point, New York mailbox and mailed from Gloria Aubrey, Rouses Point, New York to the distributor.
CDRH has reviewed a 510(k) notification received from Magnetic Health Products and determined that magnetic support devices are class III devices under section 513(f) of the Federal Food, Drug, and Cosmetic Act. Section 515(a)(2) of the Act requires class III devices to have an approved premarket approval (PMA) application before they can be legally marketed in the U.S. No PMA has been approved for these magnetic support devices
Guidance:
Districts may detain, without physical examination, all entries of magnetic support devices which can be associated clearly with promotional claims or labeling for use in the relief of pain or any other medical indications.
Product Description:
Magnetic support devices
Charge:
"The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the article appears to be an adulterated device within the meaning of section 501(f)(1) of the Act, since no premarket approval (PMA) application has been approved as required by section 515(a)(2),
OASIS charge code - NO PMA
and
"... the article appears to be misbranded within the meaning of section 502(f) of the Act, since it lacks adequate directions for use."
OASIS charge code - DIRECTIONS
OASIS charge code - NO PMA
and
"... the article appears to be misbranded within the meaning of section 502(f) of the Act, since it lacks adequate directions for use."
OASIS charge code - DIRECTIONS
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