The following data is part of a premarket notification filed by Altoona Medical Supply with the FDA for Ems/400.
| Device ID | K913272 |
| 510k Number | K913272 |
| Device Name: | EMS/400 |
| Classification | Stimulator, Muscle, Powered |
| Applicant | ALTOONA MEDICAL SUPPLY 705 2ND AVE., S.W. Altoona, IA 50009 |
| Contact | Donald A Mackenzie |
| Correspondent | Donald A Mackenzie ALTOONA MEDICAL SUPPLY 705 2ND AVE., S.W. Altoona, IA 50009 |
| Product Code | IPF |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-23 |
| Decision Date | 1991-08-22 |