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 |