The following data is part of a premarket notification filed by Shenzhen Kentro Medical Electronics Co., Ltd with the FDA for Muscle Trainer.
Device ID | K181728 |
510k Number | K181728 |
Device Name: | Muscle Trainer |
Classification | Stimulator, Muscle, Powered, For Muscle Conditioning |
Applicant | Shenzhen Kentro Medical Electronics Co., Ltd No.3, Xihu Industry Zone, Xikeng Village, Henggang Town, Longgang District Shenzhen, CN 518115 |
Contact | Zewu Zhang |
Correspondent | Rain Yip Feiying Drug & Medical Consulting Technical Service Group Rm. 3005, Area B, Bldg.1, Southward Ruifeng Business Center, Guimiao Road Shenzhen, CN 518000 |
Product Code | NGX |
CFR Regulation Number | 890.5850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-06-29 |
Decision Date | 2018-10-17 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
06924607701280 | K181728 | 000 |
06924607701273 | K181728 | 000 |
06924607701266 | K181728 | 000 |
06924607701259 | K181728 | 000 |
06924607701242 | K181728 | 000 |
06924607701235 | K181728 | 000 |
06924607701228 | K181728 | 000 |
00850033118100 | K181728 | 000 |