ZHONGSHAN QUANDE ELECTRIC FACTORY · 89-08 · CHINA
For ZHONGSHAN QUANDE ELECTRIC FACTORY, 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 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 2026-09-30.
- 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
— 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
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
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html