FIREFLY

Stimulator, Muscle, Powered, For Muscle Conditioning

FIRSTKIND LIMITED

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

Pre-market Notification Details

• Device ID: K134001
• 510k Number: K134001
• Device Name: FIREFLY
• Classification: Stimulator, Muscle, Powered, For Muscle Conditioning
• 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: NGX
• CFR Regulation Number: 890.5850 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-12-27
• Decision Date: 2014-05-15
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
05060294770459	K134001	000
05060294770503	K134001	000
05060294770107	K134001	000