510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K051197Substantially Equivalent

Aculife, Model Smw-01

Inno-Health Technology Co., Ltd., Taichung, TW / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K051197 is the FDA 510(k) clearance record for ACULIFE, MODEL SMW-01, cleared for Inno-Health Technology, Inc. on under FDA product code BWK (Stimulator, Electro-Acupuncture). FDA records list 2 510(k) clearances for Inno-Health Technology, Inc., from to . As of , FDA records show no recalls naming K051197.

Clearance record

Decision date
Received
(322 days to decision)
Product code
BWK Stimulator, Electro-Acupuncture
Device class
Unclassified
Review panel
Unknown
Applicant
Inno-Health Technology, Inc. 8f-2, # 61, Kung-Yi Rd., Taichung, TW
510(k) summary
Summary PDF
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