Reference Source

Remar (Grand Turk) Ltd. · 89-08 · UNITED KINGDOM

For Remar (Grand Turk) Ltd., import alert is 89-08; country is UNITED KINGDOM; 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 Stimulator Electro-Acupuncture; product code is 84 B - - WK Stimulator, Electro-Acupuncture; date published is 03/08/2011; address is Southall , Middlesex, England UNITED KINGDOM, verified against its source on 2026-09-30.

Firm
Remar (Grand Turk) Ltd. 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
UNITED KINGDOM verified
Address
Southall , Middlesex, England UNITED KINGDOM verified
Date published
03/08/2011 verified
Product code
84 B - - WK Stimulator, Electro-Acupuncture verified
Product
Stimulator Electro-Acupuncture verified
FDA notes
Class III verified
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

Remar (Grand Turk) Ltd. Date Published : 03/08/2011 Southall , Middlesex, England UNITED KINGDOM

— accessdata.fda.gov, retrieved 2026-09-15

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 B - - WK Stimulator, Electro-Acupuncture Date Published: 11/08/2018 Desc: Stimulator Electro-Acupuncture Notes: Class III

— all from accessdata.fda.gov, retrieved 2026-09-15

Source

Last verified against source: . Due for re-check by . This page as Markdown · OKF bundle · full dataset as JSON.

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