510(k) K181059

geko T-3 Neuromuscular Stimulator by Firstkind Limited — Product Code IPF

K181059 is an FDA 510(k) premarket notification submitted by Firstkind Limited for the device "geko T-3 Neuromuscular Stimulator". The FDA issued a decision of Substantially Equivalent on May 23, 2018. The device falls under product code IPF (Stimulator, Muscle, Powered), a Class II device regulated under 21 CFR 890.5850. Firstkind Limited has 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 23, 2018
Date Received
Apr 23, 2018
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Muscle, Powered
Device Class
Class II
Regulation Number
890.5850
Review Panel
PM
Submission Type
510(k)