Ace Tec Hk Co Limited · 89-08 · HONG KONG SAR
For Ace Tec Hk Co Limited, import alert is 89-08; country is HONG KONG SAR; 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 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 2026-09-30.
- 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
What the source says
Ace Tec Hk Co Limited Date Published : 08/01/2011 582-592 Nathan Road , Kowloon, HONG KONG SAR
— 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
89 - - - -- Physical Medicine Date Published: 08/01/2011 Desc: SYL-06 (1MHz) Physiotherapy Ultrasound SYL-07 (3 MHz) Physiotherapy Ultrasound Notes: Class II
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html