Home / 510(k) Clearances / K093322

510(k) K093322

MULTI-PURPOSE HEALTH DEVICE by Upc Medical Supplies, Inc. Dba United Pacific Co. — Product Code BWK

K093322 is an FDA 510(k) premarket notification submitted by Upc Medical Supplies, Inc. Dba United Pacific Co. for the device "MULTI-PURPOSE HEALTH DEVICE". The FDA issued a decision of Substantially Equivalent on August 5, 2010. The device falls under product code BWK (Stimulator, Electro-Acupuncture), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 5, 2010
Date Received
October 23, 2009
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