GEKO

Stimulator, Muscle, Powered

FIRSTKIND LIMITED

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

Pre-market Notification Details

• Device ID: K133638
• 510k Number: K133638
• Device Name: GEKO
• Classification: Stimulator, Muscle, Powered
• Applicant: FIRSTKIND LIMITED 231 FAIRBANKS STREET West Boylston, MA 01583
• Contact: Sheila Hemeon-heyer
• Correspondent: Sheila Hemeon-heyer; FIRSTKIND LIMITED 231 FAIRBANKS STREET West Boylston, MA 01583
• Product Code: IPF
• CFR Regulation Number: 890.5850 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-11-27
• Decision Date: 2014-08-21
• Summary: summary