510(k) K152416
K152416 is an FDA 510(k) premarket notification submitted by Parker Hannifin Corporation for the device "Indego". The FDA issued a decision of Substantially Equivalent on February 26, 2016. The device falls under product code PHL (Powered Exoskeleton), a Class II device regulated under 21 CFR 890.3480. Parker Hannifin Corporation has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 26, 2016
- Date Received
- August 26, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Powered Exoskeleton
- Device Class
- Class II
- Regulation Number
- 890.3480
- Review Panel
- NE
- Submission Type
A powered exoskeleton is a prescription device that is composed of an external, powered, motorized orthosis that is placed over a person's paralyzed or weakened lower extremity limb(s) for medical purposes.