The following data is part of a premarket notification filed by Intermedics, Inc. with the FDA for Tensmed Ii.
| Device ID | K851063 |
| 510k Number | K851063 |
| Device Name: | TENSMED II |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | INTERMEDICS, INC. P.O. BOX 617 Freeport, TX 77541 -0617 |
| Contact | Dixie Bruening |
| Correspondent | Dixie Bruening INTERMEDICS, INC. P.O. BOX 617 Freeport, TX 77541 -0617 |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-03-15 |
| Decision Date | 1985-06-04 |