The following data is part of a premarket notification filed by Myomo, Inc. with the FDA for Myomo E100.
| Device ID | K062631 |
| 510k Number | K062631 |
| Device Name: | MYOMO E100 |
| Classification | Exercise Equipment, Powered, Emg-triggered |
| Applicant | MYOMO, INC. 529 MAIN STREET SUITE 205 Boston, MA 02129 |
| Contact | Kate Zebrose |
| Correspondent | Kate Zebrose MYOMO, INC. 529 MAIN STREET SUITE 205 Boston, MA 02129 |
| Product Code | OAL |
| CFR Regulation Number | 890.1375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-05 |
| Decision Date | 2007-04-12 |
| Summary: | summary |