510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K170391Substantially Equivalent

ANSiStim-PP

Dyansys, Inc., San Mateo CA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K170391 is the FDA 510(k) clearance record for ANSiStim-PP, cleared for Dyansys, Inc. on under FDA product code BWK (Stimulator, Electro-Acupuncture). FDA records list 15 510(k) clearances for Dyansys, Inc., from to . As of , FDA records show no recalls naming K170391.

Clearance record

Decision date
Received
(29 days to decision)
Product code
BWK Stimulator, Electro-Acupuncture
Device class
Unclassified
Review panel
Unknown
Applicant
Dyansys, Inc. 300, N. Bayshore Blvd., San Mateo CA
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