MYOMO E100
FDA 510(k) clearance K062631 · decided 2007-04-12
Clearance details
- K-number
- K062631
- Device name
- MYOMO E100
- Applicant
- Myomo, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2006-09-05
- Decision date
- 2007-04-12
- Days to decision
- 219 days
- Clearance type
- Traditional
- Product code
- OAL
- Device class
- 2
- Regulation number
- 890.1375
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Boston, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.