The following data is part of a premarket notification filed by Shenzhen Konmed Technology Co., Ltd. with the FDA for Biofeedback Nerve And Muscle Stimulator.
| Device ID | K202648 |
| 510k Number | K202648 |
| Device Name: | Biofeedback Nerve And Muscle Stimulator |
| Classification | Stimulator, Muscle, Powered |
| Applicant | Shenzhen Konmed Technology Co., Ltd. 601, Building B4, Shenchengtou Creative Factory Life Science Park Shenzhen, CN 518118 |
| Contact | Tony No Last Name Provided |
| Correspondent | Tracy Che Feiying Drug & Medical Consulting Technical Service Group Rm 2401 Zhenye International Business Center, No. 3101-90, Qianhai Road Shenzhen, CN 518052 |
| Product Code | IPF |
| Subsequent Product Code | HCC |
| Subsequent Product Code | KPI |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-11 |
| Decision Date | 2020-12-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06970935830543 | K202648 | 000 |
| 06970935830536 | K202648 | 000 |