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510(k) K091933

ELECTRO-ACUPUNCTURE: ACULIFE/MODEL IDOC-01 by Inno-Health Technology, Inc. — Product Code BWK

K091933 is an FDA 510(k) premarket notification submitted by Inno-Health Technology, Inc. for the device "ELECTRO-ACUPUNCTURE: ACULIFE/MODEL IDOC-01". The FDA issued a decision of Substantially Equivalent on April 2, 2010. The device falls under product code BWK (Stimulator, Electro-Acupuncture), a Class U device. Inno-Health Technology, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 2, 2010
Date Received
June 30, 2009
Clearance Type
Special
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 Inno-Health Technology, Inc.

  • K051197 — ACULIFE, MODEL SMW-01 (March 28, 2006)

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