The following data is part of a premarket notification filed by Mednet Services, Inc. with the FDA for Medstar 100 Interferential Stimlator.
Device ID | K013082 |
510k Number | K013082 |
Device Name: | MEDSTAR 100 INTERFERENTIAL STIMLATOR |
Classification | Interferential Current Therapy |
Applicant | MEDNET SERVICES, INC. 2855 ANTHONY LN. SOUTH, #B10 St. Anthony, MN 55418 |
Contact | David L Mathews |
Correspondent | David L Mathews MEDNET SERVICES, INC. 2855 ANTHONY LN. SOUTH, #B10 St. Anthony, MN 55418 |
Product Code | LIH |
CFR Regulation Number | 882.5890 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-09-14 |
Decision Date | 2001-11-16 |
Summary: | summary |