510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K930535Substantially Equivalent

If400

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

K930535 is the FDA 510(k) clearance record for IF400, a class II device, cleared for Skylark Device Co., Ltd. on under FDA product code LIH (Interferential Current Therapy). FDA records list 20 510(k) clearances for Skylark Device Co., Ltd., from to . As of , FDA records show no recalls naming K930535.

Clearance record

Decision date
Received
(497 days to decision)
Product code
LIH Interferential Current Therapy
Regulation
21 CFR 882.5890
Device class
Class II
Review panel
Neurology
Applicant
Skylark Device Co., Ltd. 12 Floor 34, Sec. 3 Chung Shan, Taipei, Taiwan, R.O.C., TW
510(k) summary
Statement
Third party review
No

Clearances, product code LIH

Trailing 12 months

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

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