SHENZHEN FREEFLYING IND. & EXP. LTD. · 89-08 · CHINA
For SHENZHEN FREEFLYING IND. & EXP. LTD. · 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 810 Dingxin Bldg A , Nanshan District , Shenzhen, Guangdong CHINA, verified against its source on 2026-09-16.
- Firm
- SHENZHEN FREEFLYING IND. & EXP. LTD. 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
- 810 Dingxin Bldg A , Nanshan District , Shenzhen, Guangdong 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; 4/18/2014 | Class II each item verified
What the source says
SHENZHEN FREEFLYING IND. & EXP. LTD. Date Published : 04/18/2014 810 Dingxin Bldg A , Nanshan District , Shenzhen, Guangdong 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: 05/03/2021 Desc: Massager Notes: Class II; 4/18/2014 89 I - - SA Massager, Therapeutic, Electric Date Published: 04/18/2014 Desc: Massager Notes: Class II
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html