The following data is part of a premarket notification filed by Armstrong Industries, Inc. with the FDA for Simplex Tens.
| Device ID | K953982 |
| 510k Number | K953982 |
| Device Name: | SIMPLEX TENS |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | ARMSTRONG INDUSTRIES, INC. 1865 SUMMIT DR. SUITE 604 Plano, TX 75074 |
| Contact | John Landino |
| Correspondent | John Landino ARMSTRONG INDUSTRIES, INC. 1865 SUMMIT DR. SUITE 604 Plano, TX 75074 |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-23 |
| Decision Date | 1997-04-25 |