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
K981449Substantially Equivalent

Sd-956 Ultrasound Therapy

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

K981449 is the FDA 510(k) clearance record for SD-956 ULTRASOUND THERAPY, a class II device, cleared for Skylark Device Co., Ltd. on under FDA product code IMI (Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat). FDA records list 20 510(k) clearances for Skylark Device Co., Ltd., from to . As of , FDA records show no recalls naming K981449.

Clearance record

Decision date
Received
(233 days to decision)
Product code
IMI Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
Regulation
21 CFR 890.5300
Device class
Class II
Review panel
Physical Medicine
Applicant
Skylark Device Co., Ltd. 34 Chung Shan N. Rd.,, Taipei, TW
510(k) summary
Statement
Third party review
No

Clearances, product code IMI

Trailing 12 months

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

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