Medical Device Manufacturer · TW , Taipei, Taiwan, R.O.C.

Skylark Device Co., Ltd. - FDA 510(k) Cleared Devices

20 submissions · 20 cleared · Since 1991

20

Total

20

Cleared

0

Denied

FDA 510(k) Regulatory Record - Skylark Device Co., Ltd. Physical Medicine ✕

5 devices

1-5 of 5

Cleared Oct 27, 1999

ST-302 INFRAREX

Physical Medicine · 275d

Cleared Dec 11, 1998

SD-956 ULTRASOUND THERAPY

Physical Medicine · 233d

Cleared Oct 09, 1997

SD-970EMS ELECTRICAL MUSCULAR STIMULATOR

Physical Medicine · 338d

Cleared Dec 20, 1995

IT-727 (ALSO KNOWN AS IT-610, IT-600 AND DYNAPHOR II

Physical Medicine · 356d

Cleared Dec 09, 1991

EMS300, EMS400, EMS8000

Physical Medicine · 178d