The following data is part of a premarket notification filed by Medical Devices, Inc. with the FDA for Myopac (tm), Model 9600.
| Device ID | K864625 |
| 510k Number | K864625 |
| Device Name: | MYOPAC (TM), MODEL 9600 |
| Classification | Stimulator, Muscle, Powered |
| Applicant | MEDICAL DEVICES, INC. 833 THIRD ST. SOUTHWEST St. Paul, MN 55112 |
| Contact | Bruce A Macfarlane |
| Correspondent | Bruce A Macfarlane MEDICAL DEVICES, INC. 833 THIRD ST. SOUTHWEST St. Paul, MN 55112 |
| Product Code | IPF |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-11-25 |
| Decision Date | 1986-12-29 |