The following data is part of a premarket notification filed by Shaoxing Yingtuo Healthcare Co.,ltd. with the FDA for Adhesive Electrode.
| Device ID | K210448 |
| 510k Number | K210448 |
| Device Name: | Adhesive Electrode |
| Classification | Electrode, Cutaneous |
| Applicant | Shaoxing Yingtuo Healthcare Co.,Ltd. NO.176 Shungeng Road,Baiguan Street,Shangyu Area, Shaoxing City,Zhejiang Shaoxing, CN 312300 |
| Contact | Haze XU |
| Correspondent | Haze XU Shaoxing Yingtuo Healthcare Co.,Ltd. NO.176 Shungeng Road,Baiguan Street,Shangyu Area, Shaoxing City,Zhejiang Shaoxing, CN 312300 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-02-16 |
| Decision Date | 2021-08-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05033435134199 | K210448 | 000 |
| 05033435133185 | K210448 | 000 |
| 05033435133147 | K210448 | 000 |
| 05033435130979 | K210448 | 000 |
| 05033435000647 | K210448 | 000 |
| 05033435000517 | K210448 | 000 |
| 05033435000500 | K210448 | 000 |