The following data is part of a premarket notification filed by Globalcare Intl., Inc. with the FDA for Globalcare Electrode.
| Device ID | K913373 |
| 510k Number | K913373 |
| Device Name: | GLOBALCARE ELECTRODE |
| Classification | Electrode, Cutaneous |
| Applicant | GLOBALCARE INTL., INC. 220 LINDEN ST. Holyoke, MA 01040 |
| Contact | John Dunn |
| Correspondent | John Dunn GLOBALCARE INTL., INC. 220 LINDEN ST. Holyoke, MA 01040 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-29 |
| Decision Date | 1991-08-29 |