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 |