510(k) K062631
- Device
- MYOMO E100
- Applicant
- MYOMO, INC.
- 510(k) number
- K062631
- Product code
- OAL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2007-04-12
- Date received
- 2006-09-05
- Regulation
- 890.1375
- Classification name
- Exercise Equipment, Powered, Emg-triggered
- Medical specialty
- Physical Medicine
- Review panel
- Physical Medicine
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- KATE ZEBROSE
- Address
- 529 Main St. Suite 205 Boston MA US 02129 02129
Source Documents#
Legacy Summary#
summary
FDA Review#
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