AMIGO CLASSIC FD
FDA 510(k) clearance K101507 · decided 2010-07-30
Clearance details
- K-number
- K101507
- Device name
- AMIGO CLASSIC FD
- Applicant
- Amigo Mobility Intl., Inc.
- Decision
- Substantially Equivalent
- Date received
- 2010-06-01
- Decision date
- 2010-07-30
- Days to decision
- 59 days
- Clearance type
- Abbreviated
- Product code
- INI
- Device class
- 2
- Regulation number
- 890.3800
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Bridgeport, MI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.