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510(k) K840995

ACUPUNCTURE INSOLES by Lu LU Enterprise Co. , Ltd. — Product Code BWK

K840995 is an FDA 510(k) premarket notification submitted by Lu LU Enterprise Co. , Ltd. for the device "ACUPUNCTURE INSOLES". The FDA issued a decision of Substantially Equivalent on March 27, 1984. The device falls under product code BWK (Stimulator, Electro-Acupuncture), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 27, 1984
Date Received
March 8, 1984
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

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  • 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