The following data is part of a premarket notification filed by Guilin Woodpecker Medical Instrument Co., Ltd. with the FDA for Cordless Prophy System, Model: I-polish.
| Device ID | K211531 |
| 510k Number | K211531 |
| Device Name: | Cordless Prophy System, Model: I-Polish |
| Classification | Handpiece, Direct Drive, Ac-powered |
| Applicant | Guilin Woodpecker Medical Instrument Co., Ltd. Information Industrial Park, Guilin National High-Tech Zone Guilin, CN 541004 |
| Contact | Ning Jiakang |
| Correspondent | Yoyo Chen Shenzhen Joyantech Consulting Co., Ltd. 1713A, 17th Floor, Block A, Zhongguan Times Square, Liuxian Avenue, Xili Town, Nanshan District Shenzhen, CN 518100 |
| Product Code | EKX |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-05-17 |
| Decision Date | 2021-12-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 69443136123930 | K211531 | 000 |
| 00883205035400 | K211531 | 000 |
| 00883205035417 | K211531 | 000 |
| 00883205035424 | K211531 | 000 |
| 00883205035431 | K211531 | 000 |
| 00883205035448 | K211531 | 000 |
| 00883205035455 | K211531 | 000 |
| 00883205035462 | K211531 | 000 |
| 00883205035479 | K211531 | 000 |
| 06944843605975 | K211531 | 000 |
| 06944843655949 | K211531 | 000 |
| 00883205035394 | K211531 | 000 |