MyoCycle MC-2 (Home / Home + / Pro / Pro +)
FDA 510(k) clearance K213925 · decided 2022-04-25
Clearance details
- K-number
- K213925
- Device name
- MyoCycle MC-2 (Home / Home + / Pro / Pro +)
- Applicant
- Myolyn, LLC
- Decision
- Substantially Equivalent
- Date received
- 2021-12-16
- Decision date
- 2022-04-25
- Days to decision
- 130 days
- Clearance type
- Traditional
- Product code
- GZI
- Device class
- 2
- Regulation number
- 882.5810
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Gainesville, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.