Free Flying International Lte · 89-08 · CHINA
For Free Flying International Lte, import alert is 89-08; country is CHINA; 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 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 2026-09-30.
- Firm
- Free Flying International Lte 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
- CHINA verified
- Address
- 5/F Bldg 11 Tongfuyu Park Lezh , Shenzhen, CHINA verified
- Date published
- 04/18/2014 verified
- 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 each item verified
- Product
- Massager | Massager | Massager | Massager each item verified
- FDA notes
- Class II | Class II | Class II | Class II each item verified
What the source says
Free Flying International Lte Date Published : 04/18/2014 5/F Bldg 11 Tongfuyu Park Lezh , Shenzhen, CHINA
— 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
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
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html