The following data is part of a premarket notification filed by Globalcare Intl., Inc. with the FDA for Globalcare Ems.
| Device ID | K913444 |
| 510k Number | K913444 |
| Device Name: | GLOBALCARE EMS |
| Classification | Stimulator, Muscle, Powered |
| 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 | IPF |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-08-02 |
| Decision Date | 1991-10-21 |