The following data is part of a premarket notification filed by Theratech, Inc. with the FDA for Powered Muscle Stimulator.
| Device ID | K013768 |
| 510k Number | K013768 |
| Device Name: | POWERED MUSCLE STIMULATOR |
| Classification | Stimulator, Muscle, Powered |
| Applicant | THERATECH, INC. 55 NORTHERN BLVD., SUITE 200 Great Neck, NY 11021 |
| Contact | Carolann Kotula |
| Correspondent | Carolann Kotula THERATECH, INC. 55 NORTHERN BLVD., SUITE 200 Great Neck, NY 11021 |
| Product Code | IPF |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-11-13 |
| Decision Date | 2002-07-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04719872261049 | K013768 | 000 |