The following data is part of a premarket notification filed by Tohkai Precision Electrical Manufactory (shenzhen) Limited with the FDA for 2-in-1 Abdominal Muscle Training & Back Pain Relief System.
| Device ID | K152128 |
| 510k Number | K152128 |
| Device Name: | 2-in-1 Abdominal Muscle Training & Back Pain Relief System |
| Classification | Stimulator, Nerve, Transcutaneous, Over-the-counter |
| Applicant | Tohkai Precision Electrical Manufactory (Shenzhen) Limited No.3 Alley 1, Second Industrial Park Park, Jia Zi Tang, GongMing Office Shenzhen, CN 518132 |
| Contact | Yuk Wing Li |
| Correspondent | Cecilia Ceng GUANGZHOU GLOMED BIOLOGICAL TECHNOLOGY CO.,LTD SUITE 306, KECHENG MANSION, NO.121 SCIENCE ROAD, GUANGZHOU SCIENCE PARK Guangzhou, CN 510663 |
| Product Code | NUH |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-07-31 |
| Decision Date | 2015-12-23 |
| Summary: | summary |