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FDA 510(k) Application Details - K220988
Device Classification Name
More FDA Info for this Device
510(K) Number
K220988
Device Name
EksoNR
Applicant
Ekso Bionics, Inc.
1414 Harbour Way South, Suite 1201
Richmond, CA 94804 US
Other 510(k) Applications for this Company
Contact
Scott Davis
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
PHL
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/04/2022
Decision Date
06/09/2022
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
PM - Physical Medicine
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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