HELIO
FDA 510(k) clearance K120628 · decided 2012-12-19
Clearance details
- K-number
- K120628
- Device name
- HELIO
- Applicant
- Motion Composites
- Decision
- Substantially Equivalent
- Date received
- 2012-03-01
- Decision date
- 2012-12-19
- Days to decision
- 293 days
- Clearance type
- Traditional
- Product code
- IOR
- Device class
- 1
- Regulation number
- 890.3850
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Saint-Roch-De-L' Achigan, CA
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.