# Free Flying International Lte · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

For Free Flying International Lte · 89-08 · CHINA, 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 CHINA; product is Massager | Massager | Massager | Massager; product code is 84 N - - YW Stimulator, nerve, electrical, transcutaneous, with limited output, for pain relief | 84 N - - YX Stimulator, electrical, transcutaneous, with limted output, for aesthetic purposes | 87 L - - PQ Stimulator, ultrasound and muscle, for use other than applying therapeutic deep | 89 I - - SA Massager, Therapeutic, Electric; date published is 04/18/2014; address is 5/F Bldg 11 Tongfuyu Park Lezh , Shenzhen, CHINA, verified against its source on 2026-09-16.

- **Firm:** Free Flying International Lte _(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:** CHINA _(verified: appears in the quote below)_
- **Address:** 5/F Bldg 11 Tongfuyu Park Lezh , Shenzhen, CHINA _(verified: appears in the quote below)_
- **Date published:** 04/18/2014 _(verified: appears in the quote below)_
- **Product code:** 84 N - - YW Stimulator, nerve, electrical, transcutaneous, with limited output, for pain relief | 84 N - - YX Stimulator, electrical, transcutaneous, with limted output, for aesthetic purposes | 87 L - - PQ Stimulator, ultrasound and muscle, for use other than applying therapeutic deep | 89 I - - SA Massager, Therapeutic, Electric _(verified: each item appears in the quote below)_
- **Product:** Massager | Massager | Massager | Massager _(verified: each item appears in the quote below)_
- **FDA notes:** Class II | Class II | Class II | Class II _(verified: each item appears in the quote below)_

## What the source says

> Free Flying International Lte Date Published : 04/18/2014 5/F Bldg 11 Tongfuyu Park Lezh , Shenzhen, CHINA 84 N - - YW Stimulator, nerve, electrical, transcutaneous, with limited output, for pain relief Date Published: 04/18/2014 Desc: Massager Notes: Class II 84 N - - YX Stimulator, electrical, transcutaneous, with limted output, for aesthetic purposes Date Published: 04/18/2014 Desc: Massager Notes: Class II 87 L - - PQ Stimulator, ultrasound and muscle, for use other than applying therapeutic deep Date Published: 05/30/2019 Desc: Massager Notes: Class II 89 I - - SA Massager, Therapeutic, Electric Date Published: 04/18/2014 Desc: Massager 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/).