The following data is part of a premarket notification filed by Henley Intl. with the FDA for Team-mc Ii.
| Device ID | K921828 |
| 510k Number | K921828 |
| Device Name: | TEAM-MC II |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | HENLEY INTL. 104 INDUSTRIAL BLVD., Sugar Land, TX 77470 |
| Contact | Ernest J Henlely |
| Correspondent | Ernest J Henlely HENLEY INTL. 104 INDUSTRIAL BLVD., Sugar Land, TX 77470 |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-04-16 |
| Decision Date | 1992-09-22 |