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 |
00854314007060 | 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 |
00854314007169 | K130723 | 000 |
00854314007206 | 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 |
00031262111746 | K130723 | 000 |