The following data is part of a premarket notification filed by Shenzhen As-tec Technology Co., Ltd with the FDA for Tens And Powered Muscle Stimulator.
Device ID | K143268 |
510k Number | K143268 |
Device Name: | TENS AND POWERED MUSCLE STIMULATOR |
Classification | Stimulator, Nerve, Transcutaneous, Over-the-counter |
Applicant | SHENZHEN AS-TEC TECHNOLOGY CO., LTD 2C XINGBAOYI INDUSTRIAL BLD., HOUTING VILLAGE, BEITING RD., SHAJING Shenzhen, CN 518104 |
Contact | Connie Li |
Correspondent | Doris Dong SHANGHAI CV TECHNOLOGY CO., LTD ROOM 1706 YUESHA BUILDING, NO.128 SONGLE RD., SONGJIANG AREA Shanghai, CN 201600 |
Product Code | NUH |
CFR Regulation Number | 882.5890 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-11-13 |
Decision Date | 2015-07-21 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00862081000320 | K143268 | 000 |
06970890320103 | K143268 | 000 |
06970890320097 | K143268 | 000 |
06970890320080 | K143268 | 000 |
00697089032727 | K143268 | 000 |
06970890327065 | K143268 | 000 |
06970890327102 | K143268 | 000 |
06970890326280 | K143268 | 000 |
06970890326105 | K143268 | 000 |
06970890328963 | K143268 | 000 |
00862081000375 | K143268 | 000 |
16970890320292 | K143268 | 000 |
10810038633357 | K143268 | 000 |
10810038634842 | K143268 | 000 |
10810038636044 | K143268 | 000 |
06970890320325 | K143268 | 000 |
06970890321704 | K143268 | 000 |
06970890329540 | K143268 | 000 |
06970890320288 | K143268 | 000 |
06970890329541 | K143268 | 000 |
06970890329283 | K143268 | 000 |
06970890320010 | K143268 | 000 |
06970890320009 | K143268 | 000 |
06970890320008 | K143268 | 000 |
00697089032723 | K143268 | 000 |
06970890327062 | K143268 | 000 |
06970890327101 | K143268 | 000 |
06970890326463 | K143268 | 000 |
06970890326103 | K143268 | 000 |
06970890328960 | K143268 | 000 |
06970890321701 | K143268 | 000 |
10855944007908 | K143268 | 000 |
06970890326287 | K143268 | 000 |
10810038630257 | K143268 | 000 |
06970890320301 | K143268 | 000 |