The following data is part of a premarket notification filed by Habalan Med & Beauty Co.,ltd with the FDA for Pobling Miity 2.
| Device ID | K163550 |
| 510k Number | K163550 |
| Device Name: | Pobling MIITY 2 |
| Classification | Stimulator, Transcutaneous Electrical, Aesthetic Purposes |
| Applicant | HABALAN MED & BEAUTY CO.,LTD 907, 219, GASANDIGITAL 1-RO, GEUMCHEON-GU Seoul, KR 08501 |
| Contact | Ray Jeon |
| Correspondent | Peter Chung PLUS GLOBAL 300 ATWOOD Pittsburgh, PA 15213 |
| Product Code | NFO |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-19 |
| Decision Date | 2017-12-20 |