510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K946337Substantially Equivalent

It-727 (Also Known as It-610, It-600 and Dynaphor II

Skylark Device Co., Ltd., Taiwan, R.O.C., TW / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K946337 is the FDA 510(k) clearance record for IT-727 (ALSO KNOWN AS IT-610, IT-600 AND DYNAPHOR II, a class II device, cleared for Skylark Device Co., Ltd. on under FDA product code EGJ (Device, Iontophoresis, Other Uses). FDA records list 20 510(k) clearances for Skylark Device Co., Ltd., from to . As of , FDA records show no recalls naming K946337.

Clearance record

Decision date
Received
(356 days to decision)
Product code
EGJ Device, Iontophoresis, Other Uses
Regulation
21 CFR 890.5525
Device class
Class II
Review panel
Physical Medicine
Applicant
Skylark Device Co., Ltd. P.O. Box 68-502 Taipei, Taiwan, R.O.C., TW
510(k) summary
Summary
Third party review
No

Clearances, product code EGJ

Trailing 12 months

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

FDA records show no clearances under product code EGJ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code EGJ, 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