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510(k) K081943

MODEL ES-130 by Ito Co., Ltd. — Product Code BWK

K081943 is an FDA 510(k) premarket notification submitted by Ito Co., Ltd. for the device "MODEL ES-130". The FDA issued a decision of Substantially Equivalent on November 24, 2008. The device falls under product code BWK (Stimulator, Electro-Acupuncture), a Class U device. Ito Co., Ltd. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 24, 2008
Date Received
July 8, 2008
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 by Ito Co., Ltd.

  • K203525 — D function (May 5, 2021)
  • K112520 — US-101L, US-103S (October 26, 2011)
  • K081247 — TM-400 (August 25, 2008)
  • K032793 — US-100 PORTABLE ULTRASOUND THERAPY UNIT (October 9, 2003)
  • K022846 — SW-180 SHORTWAVE THERAPY UNIT (January 28, 2003)
  • K990787 — TRIO 300 (October 20, 1999)
  • K992545 — TM-300 TRACTION SYSTEM (September 1, 1999)

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