Q6 Edge EM
FDA 510(k) clearance K143383 · decided 2015-07-23
Clearance details
- K-number
- K143383
- Device name
- Q6 Edge EM
- Applicant
- Pride Mobility Product Corporation
- Decision
- Substantially Equivalent
- Date received
- 2014-11-25
- Decision date
- 2015-07-23
- Days to decision
- 240 days
- Clearance type
- Traditional
- Product code
- ITI
- Device class
- 2
- Regulation number
- 890.3860
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Exeter, PA, US
- Third-party review
- No
- Expedited review
- No
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