The following data is part of a premarket notification filed by Armstrong Industries, Inc. Dha Mediquip Int. Dha S with the FDA for Sterling Medical Impulse 3 Stimulator.
| Device ID | K121305 |
| 510k Number | K121305 |
| Device Name: | STERLING MEDICAL IMPULSE 3 STIMULATOR |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | ARMSTRONG INDUSTRIES, INC. DHA MEDIQUIP INT. DHA S 7290 VIRGINIA PARKWAY SUITE 3000 Mckinney, TX 75071 |
| Contact | Ralph H Armstrong |
| Correspondent | Ralph H Armstrong ARMSTRONG INDUSTRIES, INC. DHA MEDIQUIP INT. DHA S 7290 VIRGINIA PARKWAY SUITE 3000 Mckinney, TX 75071 |
| Product Code | GZJ |
| Subsequent Product Code | IPF |
| Subsequent Product Code | LIH |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-05-01 |
| Decision Date | 2012-09-25 |
| Summary: | summary |