ZHONGSHAN QUANDE ELECTRIC FACTORY · 89-08 · CHINA
For ZHONGSHAN QUANDE ELECTRIC FACTORY · 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 SL-50 Cluster Laser | SL-50 Cluster Laser | Electric Acupuncture Pen | SL-50 Cluster Laser; product code is 79 G - - EX Powered laser surgical instruments | 79 O - - NF Powered light based non-laser surgical instrument with thermal effect | 84 B - - WK Stimulator, Electro-Acupuncture | 89 N - - HN Lamp, Non-Heating, for Adjunctive Use in Pain Therapy; date published is 07/11/2011; address is TANBEI INDUSTRIAL ZONE , TANBEL YUANXING ROAD, DONGSHENG , Zhongshan, CHINA, verified against its source on 2026-09-16.
- Firm
- ZHONGSHAN QUANDE ELECTRIC FACTORY 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
- TANBEI INDUSTRIAL ZONE , TANBEL YUANXING ROAD, DONGSHENG , Zhongshan, CHINA verified
- Date published
- 07/11/2011 verified
- Product code
- 79 G - - EX Powered laser surgical instruments | 79 O - - NF Powered light based non-laser surgical instrument with thermal effect | 84 B - - WK Stimulator, Electro-Acupuncture | 89 N - - HN Lamp, Non-Heating, for Adjunctive Use in Pain Therapy each item verified
- Product
- SL-50 Cluster Laser | SL-50 Cluster Laser | Electric Acupuncture Pen | SL-50 Cluster Laser each item verified
- FDA notes
- Class II | Class II | Class II | Class II each item verified
What the source says
ZHONGSHAN QUANDE ELECTRIC FACTORY Date Published : 07/11/2011 TANBEI INDUSTRIAL ZONE , TANBEL YUANXING ROAD, DONGSHENG , Zhongshan, CHINA 79 G - - EX Powered laser surgical instruments Date Published: 07/11/2011 Desc: SL-50 Cluster Laser Notes: Class II 79 O - - NF Powered light based non-laser surgical instrument with thermal effect Date Published: 07/11/2011 Desc: SL-50 Cluster Laser Notes: Class II 84 B - - WK Stimulator, Electro-Acupuncture Date Published: 11/08/2018 Desc: Electric Acupuncture Pen Notes: Class II 89 N - - HN Lamp, Non-Heating, for Adjunctive Use in Pain Therapy Date Published: 07/11/2011 Desc: SL-50 Cluster Laser Notes: Class II
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html