Geko™ T-2 And Geko™ Plus R-2 Neuromuscular Stimulators

Stimulator, Muscle, Powered

FIRSTKIND LIMITED

The following data is part of a premarket notification filed by Firstkind Limited with the FDA for Geko™ T-2 And Geko™ Plus R-2 Neuromuscular Stimulators.

Pre-market Notification Details

• Device ID: K163125
• 510k Number: K163125
• Device Name: Geko™ T-2 And Geko™ Plus R-2 Neuromuscular Stimulators
• Classification: Stimulator, Muscle, Powered
• Applicant: FIRSTKIND LIMITED HAWK HOUSE PEREGRINE BUSINESS PARK High Wycombe, GB Hp13 7dl
• Contact: Neil Buckley
• Correspondent: Sheila Hemeon-heyer; HEYER REGULATORY SOLUTIONS LLC 125 CHERRY LANE Amherst, MA 01002
• Product Code: IPF
• CFR Regulation Number: 890.5850 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-11-08
• Decision Date: 2017-04-10
• Summary: summary