# Ace Tec Hk Co Limited · 89-08 · HONG KONG SAR — FDA import alert red lists: firms subject to detention without physical examination

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: appears in the quote below)_
- **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: appears in the quote below)_
- **Address:** 582-592 Nathan Road , Kowloon, HONG KONG SAR _(verified: appears in the quote below)_
- **Date published:** 08/01/2011 _(verified: appears in the quote below)_
- **Product code:** 89 - - - -- Physical Medicine _(verified: appears in the quote below)_
- **Product:** SYL-06 (1MHz) Physiotherapy Ultrasound SYL-07 (3 MHz) Physiotherapy Ultrasound _(verified: appears in the quote below)_
- **FDA notes:** Class II _(verified: appears in the quote below)_

## 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

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).