The following data is part of a premarket notification filed by Armstrong Industries, Inc. with the FDA for Sterling Tens.
| Device ID | K891118 |
| 510k Number | K891118 |
| Device Name: | STERLING TENS |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | ARMSTRONG INDUSTRIES, INC. 1202 RICHARDSON DRIVE STE.309 Richardson, TX 75080 |
| Contact | Becky Horn |
| Correspondent | Becky Horn ARMSTRONG INDUSTRIES, INC. 1202 RICHARDSON DRIVE STE.309 Richardson, TX 75080 |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-02 |
| Decision Date | 1989-09-06 |