Reference Source

Ace Tec Hk Co Limited · 89-08 · HONG KONG SAR

For Ace Tec Hk Co Limited · 89-08 · HONG KONG SAR, 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 HONG KONG SAR; product is SYL-06 (1MHz) Physiotherapy Ultrasound SYL-07 (3 MHz) Physiotherapy Ultrasound; product code is 89 - - - -- Physical Medicine; date published is 08/01/2011; address is 582-592 Nathan Road , Kowloon, HONG KONG SAR, verified against its source on 2026-09-16.

Firm
Ace Tec Hk Co Limited 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
HONG KONG SAR verified
Address
582-592 Nathan Road , Kowloon, HONG KONG SAR verified
Date published
08/01/2011 verified
Product code
89 - - - -- Physical Medicine verified
Product
SYL-06 (1MHz) Physiotherapy Ultrasound SYL-07 (3 MHz) Physiotherapy Ultrasound 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

Ace Tec Hk Co Limited Date Published : 08/01/2011 582-592 Nathan Road , Kowloon, HONG KONG SAR 89 - - - -- Physical Medicine Date Published: 08/01/2011 Desc: SYL-06 (1MHz) Physiotherapy Ultrasound SYL-07 (3 MHz) Physiotherapy Ultrasound Notes: Class II

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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