The following data is part of a premarket notification filed by Globalcare/bay Medical Corp. with the FDA for Tx 3 Tens Modified.
| Device ID | K913532 |
| 510k Number | K913532 |
| Device Name: | TX 3 TENS MODIFIED |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | GLOBALCARE/BAY MEDICAL CORP. 220 LINDEN ST. Holyoke, MA 01040 |
| Contact | John Dunn |
| Correspondent | John Dunn GLOBALCARE/BAY MEDICAL CORP. 220 LINDEN ST. Holyoke, MA 01040 |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-08-05 |
| Decision Date | 1991-11-22 |