The following data is part of a premarket notification filed by Medical Devices, Inc. with the FDA for Myostim(tm), Model 6600.
Device ID | K872753 |
510k Number | K872753 |
Device Name: | MYOSTIM(TM), MODEL 6600 |
Classification | Stimulator, Muscle, Powered |
Applicant | MEDICAL DEVICES, INC. 833 THIRD ST. SOUTHWEST St. Paul, MN 55112 |
Contact | Bruce Macfarlane,phd |
Correspondent | Bruce Macfarlane,phd MEDICAL DEVICES, INC. 833 THIRD ST. SOUTHWEST St. Paul, MN 55112 |
Product Code | IPF |
CFR Regulation Number | 890.5850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-07-13 |
Decision Date | 1987-10-01 |