Reference Source

Dr-ho's Inc · 89-08 · CANADA

For Dr-ho's Inc · 89-08 · CANADA, import alert is 89-08; 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)"; country is CANADA; product is Neck Comforter | Neck Comforter; product code is 84 H - - ST Apparatus, traction, non-powered | 89 K - - NM Device, Pressure Applying; date published is 10/01/2010; address is 13-176 Bullock Dr , Markham, Ontario CANADA, verified against its source on 2026-09-16.

Firm
Dr-ho's Inc 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
13-176 Bullock Dr , Markham, Ontario CANADA verified
Date published
10/01/2010 verified
Product code
84 H - - ST Apparatus, traction, non-powered | 89 K - - NM Device, Pressure Applying each item verified
Product
Neck Comforter | Neck Comforter each item verified
FDA notes
Class I | Class I each item verified
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

Dr-ho's Inc Date Published : 10/01/2010 13-176 Bullock Dr , Markham, Ontario CANADA 84 H - - ST Apparatus, traction, non-powered Date Published: 11/08/2018 Desc: Neck Comforter Notes: Class I 89 K - - NM Device, Pressure Applying Date Published: 10/01/2010 Desc: Neck Comforter Notes: Class I

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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