The following data is part of a premarket notification filed by Famidoc Technology Co., Ltd with the FDA for Fdes106 Mini Tens&ems Device,fdes106 Multi-function Mini Tens&ems Device,fdes105 Pain Relief Plaster,fdes107 Abdominal.
| Device ID | K130723 |
| 510k Number | K130723 |
| Device Name: | FDES106 MINI TENS&EMS DEVICE,FDES106 MULTI-FUNCTION MINI TENS&EMS DEVICE,FDES105 PAIN RELIEF PLASTER,FDES107 ABDOMINAL |
| Classification | Stimulator, Muscle, Powered, For Muscle Conditioning |
| Applicant | FAMIDOC TECHNOLOGY CO., LTD No.212 Yilong Road, Hexi Industrial Zone, Jinxia, Changan Town Dongguan, CN 523853 |
| Contact | Reanny Wang |
| Correspondent | Reanny Wang FAMIDOC TECHNOLOGY CO., LTD No.212 Yilong Road, Hexi Industrial Zone, Jinxia, Changan Town Dongguan, CN 523853 |
| Product Code | NGX |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-18 |
| Decision Date | 2014-02-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10311917176403 | K130723 | 000 |
| 00854314007022 | K130723 | 000 |
| 06970389634162 | K130723 | 000 |
| 06970389634087 | K130723 | 000 |
| 00818218024790 | K130723 | 000 |
| 00818218024783 | K130723 | 000 |
| 00818218024776 | K130723 | 000 |
| 00818218029047 | K130723 | 000 |
| 06970389634988 | K130723 | 000 |
| 06970389634056 | K130723 | 000 |
| 00031262108500 | K130723 | 000 |
| 00031262111746 | K130723 | 000 |
| 06970389630898 | K130723 | 000 |
| 00854314007060 | K130723 | 000 |
| 00854314007169 | K130723 | 000 |
| 10311917176397 | K130723 | 000 |
| 10311917176380 | K130723 | 000 |
| 00818218024080 | K130723 | 000 |
| 00818218024073 | K130723 | 000 |
| 10818218024056 | K130723 | 000 |
| 00854314007527 | K130723 | 000 |
| 00854314007510 | K130723 | 000 |
| 00854314007503 | K130723 | 000 |
| 00854314007183 | K130723 | 000 |
| 00372217037019 | K130723 | 000 |
| 00854314007268 | K130723 | 000 |
| 00854314007206 | K130723 | 000 |
| 00194346469680 | K130723 | 000 |