The following data is part of a premarket notification filed by Famidoc Technology Co., Ltd with the FDA for Fdes100(tens And Ems Stimulator, Fdes102(ed402) Tens Stimulator.
| Device ID | K113010 |
| 510k Number | K113010 |
| Device Name: | FDES100(TENS AND EMS STIMULATOR, FDES102(ED402) TENS STIMULATOR |
| Classification | Stimulator, Muscle, Powered |
| Applicant | FAMIDOC TECHNOLOGY CO., LTD East 2/F,Zhixiang Building,71 BLOCK BAOAN DISTRICT Shenzhen, CN 518101 |
| Contact | Cao Liang |
| Correspondent | Cao Liang FAMIDOC TECHNOLOGY CO., LTD East 2/F,Zhixiang Building,71 BLOCK BAOAN DISTRICT Shenzhen, CN 518101 |
| Product Code | IPF |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-10-11 |
| Decision Date | 2012-12-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06970389634018 | K113010 | 000 |
| 06970389634025 | K113010 | 000 |
| 06970389634032 | K113010 | 000 |
| 00818218024806 | K113010 | 000 |
| 00818218024813 | K113010 | 000 |
| M368GFDF52 | K113010 | 000 |
| 00854314007220 | K113010 | 000 |
| 00854314007237 | K113010 | 000 |
| 06970389630096 | K113010 | 000 |
| 06970389630102 | K113010 | 000 |
| 06970389634001 | K113010 | 000 |