Firstkind L T D

FDA Filings

This page includes the latest FDA filings for Firstkind L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3011197543
• FEI Number: 3011197543
• Name: FIRSTKIND LTD
• Owner & Operator: Firstkind Ltd
• Contact Address: Hawk House Peregrine Business Park; High Wycombe GB-BKM Buckinghamshire HP13 7DL GB
• Official Correspondent:
  • Neil Buckley
  • 44-1494-572040-x
• US Agent:
  • Sheila Hemeon-Heyer
  • Heyer Regulatory Solutions
  • 413 3308578
  • sheila@heyer-regulatory.com
• Importing Logistics Registration:
  • Importer: AMSA Consulting
  • Address: 2276 Evans Street ; Fullerton, CA 92833 UNITED STATES
• Importing Logistics Registration:
  • Importer: Atlanta Braves
  • Address: Turner Field 755 Hank Aaron Dr. ; Atlanta, GA 30315 UNITED STATES
• Importing Logistics Registration:
  • Importer: Atlanta Hawks
  • Address: 1 Philips Drive ; Atlanta, GA 30303 UNITED STATES
• Importing Logistics Registration:
  • Importer: Barrow Neurological Institute
  • Address: 350 W Thomas Rd ; Phoenix, AZ 85013 UNITED STATES
• Importing Logistics Registration:
  • Importer: Chris Culliver
  • Address: 40445 Diggins Court ; Leesburg, VA 20175 UNITED STATES
• Importing Logistics Registration:
  • Importer: CLEVELAND BROWNS FOOTBALL
  • Address: 76 Lou Groza Blvd ; Berea, OH 44017 UNITED STATES
  • Importer Type: End User
• Importing Logistics Registration:
  • Importer: Dr. Orr Limpisvasti
  • Address: 1590D Rosecrans Avenue, #254 ; Manhattan Beach, CA 90266 UNITED STATES
• Importing Logistics Registration:
  • Importer: EXO Opportunity Fund LLC
  • Address: Apt. 2209 401 N. Fort Lauderdale Beach BVLD ; Fort Lauderdale, FL 33304 UNITED STATES
• Importing Logistics Registration:
  • Importer: San Francisco 49ers
  • Address: SAS Performance Facility 4949 Marie P ; Santa Clara, CA 95054 UNITED STATES
• Importing Logistics Registration:
  • Importer: The Spine Institute on the Emerald Coast
  • Address: 155 Crystal Beach Drive #200 ; Destin, FL 32541 UNITED STATES
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: Hawk House Peregrine Business Park; High Wycombe Buckinghamshire, HP13 7DL GB
• Establishment Type:
  • Develop Specifications But Do Not Manufacture At This Facility
  • Complaint File Establishment per 21 CFR 820.198

FDA Filings

Device Company	Device	Date
GUDID 05060294771609 FIRSTKIND LTD	geko W3US01	2022-06-22
PMN K220327 Firstkind Limited	Geko W-3	2022-03-04
GUDID 05060294770688 FIRSTKIND LTD	geko MA2RW10	2020-11-30
GUDID 05060294770503 FIRSTKIND LTD	geko MK1RW02	2020-11-30
GUDID 05060294770107 FIRSTKIND LTD	firefly SK1RW02	2020-11-30
GUDID 05060294771708 FIRSTKIND LTD	geko T3USP2-05	2020-07-14
GUDID 05060294771654 FIRSTKIND LTD	firefly ST2US25	2020-07-14
PMN K201131 Firstkind Limited	Firefly T-2	2020-05-28
PMN K193045 | IPF FIRSTKIND LTD	geko W-2	2020-03-17
PMN K193045 Firstkind Limited	Geko™ W-2	2020-01-18
GUDID 05060294771333 FIRSTKIND LTD	geko T3US02	2019-10-23
GUDID 05060294770749 FIRSTKIND LTD	geko plus MR2US25	2019-10-23
GUDID 05060294770671 FIRSTKIND LTD	geko MT2US02	2019-10-23
GUDID 05060294770657 FIRSTKIND LTD	geko MT2US25	2019-10-23
GUDID 05060294770459 FIRSTKIND LTD	firefly ST1US25	2019-10-23
PMN K191113 Firstkind Limited	Geko T-2 And Geko T-3 Neuromuscular Stimulators	2019-09-18
PMN K181059 | IPF FIRSTKIND LTD	geko T-3	2018-05-30
PMN K181059 Firstkind Limited	Geko T-3 Neuromuscular Stimulator	2018-05-23
PMN K180082 Firstkind Ltd	Geko T-2 And Geko Plus R-2	2018-02-11
PMN K163125 FIRSTKIND LIMITED	Geko™ T-2 And Geko™ Plus R-2 Neuromuscular Stimulators	2017-04-10
PMN K160299 FIRSTKIND LIMITED	Geko(TM) Plus R-2 Neuromuscular Stimulator	2016-04-08
PMN K152677 | IPF FIRSTKIND LTD	geko T-2	2015-11-03
PMN K152677 FIRSTKIND LIMITED	Geko T-2 Neuromuscular Stimulator	2015-10-23
PMN K134001 | NGX FIRSTKIND LTD	firefly	2014-09-05
PMN K133638 FIRSTKIND LIMITED	GEKO	2014-08-21
PMN K134001 FIRSTKIND LIMITED	FIREFLY	2014-05-15