Reference Source

Pronto Innovations · 89-08 · CANADA

For Pronto Innovations, import alert is 89-08; country is CANADA; 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 Motion Relief Wrist Bands; product code is 84 M - - VV Device, Acupressure; date published is 03/09/2012; address is 601 Gordon Baker Rd , North York, Ontario CANADA, verified against its source on 2026-09-30.

Firm
Pronto Innovations 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
CANADA verified
Address
601 Gordon Baker Rd , North York, Ontario CANADA verified
Date published
03/09/2012 verified
Product code
84 M - - VV Device, Acupressure verified
Product
Motion Relief Wrist Bands verified
FDA notes
class II verified
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

Pronto Innovations Date Published : 03/09/2012 601 Gordon Baker Rd , North York, Ontario CANADA

— 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 M - - VV Device, Acupressure Date Published: 03/09/2012 Desc: Motion Relief Wrist Bands Notes: class II

— 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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