The following data is part of a premarket notification filed by Bio Protech, Inc. with the FDA for Cutaneous Electrodes.
| Device ID | K142099 |
| 510k Number | K142099 |
| Device Name: | CUTANEOUS ELECTRODES |
| Classification | Electrode, Cutaneous |
| Applicant | BIO PROTECH, INC. Donghwa Medical Instrument Complex, 151-3 Donghwagongdan-ro, Munmak-eup Wonju-si, Gangwon-do, KR 220-801 |
| Contact | Terry Kim |
| Correspondent | Kevin Han BIO PROTECH USA, INC. 2601 Walnut Ave Tustin, CA 92780 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-01 |
| Decision Date | 2014-11-17 |