The following data is part of a premarket notification filed by Armstrong Industries, Inc. with the FDA for Impulse Hvg.
| Device ID | K970847 |
| 510k Number | K970847 |
| Device Name: | IMPULSE HVG |
| Classification | Stimulator, Muscle, Powered |
| Applicant | ARMSTRONG INDUSTRIES, INC. 801 JUPITER RD., SUITE 102 Plano, TX 75074 |
| Contact | John P Landino |
| Correspondent | John P Landino ARMSTRONG INDUSTRIES, INC. 801 JUPITER RD., SUITE 102 Plano, TX 75074 |
| Product Code | IPF |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-07 |
| Decision Date | 1997-09-10 |