510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K014273Substantially Equivalent

Acustim

S.H.P. Intl. Pty., Ltd., Fullarton, S.A., AU / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K014273 is the FDA 510(k) clearance record for ACUSTIM, cleared for S.H.P. Intl. Pty., Ltd. on under FDA product code BWK (Stimulator, Electro-Acupuncture). FDA records list 2 510(k) clearances for S.H.P. Intl. Pty., Ltd., from to . As of , FDA records show no recalls naming K014273.

Clearance record

Decision date
Received
(167 days to decision)
Product code
BWK Stimulator, Electro-Acupuncture
Device class
Unclassified
Review panel
Unknown
Applicant
S.H.P. Intl. Pty., Ltd. 5/212 Glen Osmond Rd., Fullarton, S.A., AU
510(k) summary
Summary
Third party review
No

Clearances, product code BWK

Trailing 12 months

FDA records hold no clearances under product code BWK in the trailing twelve months.

FDA records show no clearances under product code BWK in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code BWK, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260