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510(k) K201131

firefly T-2 by Firstkind Limited — Product Code NGX

K201131 is an FDA 510(k) premarket notification submitted by Firstkind Limited for the device "firefly T-2". The FDA issued a decision of Substantially Equivalent on May 28, 2020. The device falls under product code NGX (Stimulator, Muscle, Powered, For Muscle Conditioning), a Class II device regulated under 21 CFR 890.5850. Firstkind Limited has 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 28, 2020
Date Received
Apr 28, 2020
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Muscle, Powered, For Muscle Conditioning
Device Class
Class II
Regulation Number
890.5850
Review Panel
PM
Submission Type
510(k)

A powered muscle stimulator for muscle conditioning is a device used for other than medical purposes to apply an electrical current to electrodes on a person's skin to temporarily affect the stimulated muscle's contractile properties, force output, and/or fatigue resistance. Unlike the classified Powered Muscle Stimulator devices intended for use in physical medicine and rehabilitation, this device is not intended for use in patients with medical conditions and is intended only for muscle conditioning purposes.

Other clearances by Firstkind Limited

  • K220327 — geko W-3 (Mar 4, 2022)
  • K212762 — geko W-2 (Nov 29, 2021)
  • K193045 — geko™ W-2 (Jan 18, 2020)
  • K191113 — geko T-2 and geko T-3 Neuromuscular Stimulators (Sep 18, 2019)
  • K181059 — geko T-3 Neuromuscular Stimulator (May 23, 2018)
  • K163125 — geko™ T-2 and geko™ Plus R-2 Neuromuscular Stimulators (Apr 10, 2017)
  • K160299 — geko(TM) Plus R-2 Neuromuscular Stimulator (Apr 8, 2016)
  • K152677 — geko T-2 Neuromuscular Stimulator (Oct 23, 2015)
  • K133638 — GEKO (Aug 21, 2014)
  • K134001 — FIREFLY (May 15, 2014)

Other clearances for product code NGX

  • K253790 — High Intensity Focused Electromagnetic Stimulation Device (FE60) (Aug 13, 2026)
  • K253926 — Diacore (Apr 10, 2026)
  • K253636 — Zionic Pro Max (EMS) (Mar 12, 2026)
  • K253408 — CoolTone (Jan 16, 2026)
  • K252154 — Portable Electro Stimulation Therapy Device (LGT-2320BE, LGT-2320ME, and… (Dec 9, 2025)
  • K253478 — Motive™ Muscle Stimulator for Lower Back (OT01-1003) (Nov 6, 2025)
  • K251594 — truFlex (Aug 28, 2025)
  • K251706 — TENS and EMS Unit (Jul 30, 2025)
  • K251378 — CoolTone (Jul 14, 2025)
  • K251746 — Pure Impact (Jul 2, 2025)

FDA data resources