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510(k) K050123

P-STIM SYSTEM by Neuroscience Therapy Corp. — Product Code BWK

K050123 is an FDA 510(k) premarket notification submitted by Neuroscience Therapy Corp. for the device "P-STIM SYSTEM". The FDA issued a decision of Substantially Equivalent on March 30, 2006. The device falls under product code BWK (Stimulator, Electro-Acupuncture), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 30, 2006
Date Received
January 19, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Electro-Acupuncture
Device Class
Class U
Regulation Number
Review Panel
NE
Submission Type

Other clearances for product code BWK

  • K244030 — Needle Stimulator (CMNS6-1 PLUS, CMNS6-3) (March 28, 2025)
  • K220153 — Needle Stimulator (Model: RJNS6-1) (March 18, 2022)
  • K202861 — Needle Stimulator (August 27, 2021)
  • K200636 — AXUS ES-5 Electro-Acupuncture Device (February 3, 2021)
  • K170391 — ANSiStim-PP (March 9, 2017)
  • K152571 — Stivax (May 26, 2016)
  • K141168 — ANSISTIM (May 15, 2015)
  • K133980 — PANTHEON ELECTROSTIMULATOR (November 7, 2014)
  • K140530 — Electro Auricular Device (October 2, 2014)
  • K140788 — P-STIM (June 27, 2014)

FDA data resources