Geko™ W-2

Stimulator, Muscle, Powered

Firstkind Limited

The following data is part of a premarket notification filed by Firstkind Limited with the FDA for Geko™ W-2.

Pre-market Notification Details

• Device ID: K193045
• 510k Number: K193045
• Device Name: Geko™ W-2
• 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: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-11-01
• Decision Date: 2020-01-18

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
05060294770688	K193045	000