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. Neurology ✕

14 devices

1-14 of 14

Cleared Dec 09, 1998

BATCH #6060 CONDUCTIVE GEL

Neurology · 33d

Cleared Aug 14, 1998

GB-1002 TENS WITH MASSAGE

Neurology · 647d

Cleared Mar 06, 1998

IF-727 INTERFERENTIAL STIMULATOR

Neurology · 88d

Cleared Feb 13, 1997

SD-610M(ALSO KNOWN AS STANDARD TENS, SD-609M,SD-611M, GLC-I STANDARD)

Neurology · 150d

Cleared Jun 26, 1995

PGS123 AND HVS-123

Neurology · 181d

Cleared Jul 11, 1994

BIO SDP (AKA SATURN SD, GLC-III SD & STAT-SD)

Neurology · 326d

Cleared Jun 14, 1994

Neurology · 497d

Cleared Jun 09, 1994

Neurology · 463d

Cleared Jan 22, 1993

SD-602 SD MODE 11, SD-603 SD MOD 111

Neurology · 70d

Cleared Oct 23, 1992

Neurology · 79d

Cleared Oct 15, 1992

SD-605 SD II PROGRAM

Neurology · 71d

Cleared Oct 13, 1992

MICRO 100,200,300, & 400 TENS

Neurology · 99d

Cleared Feb 14, 1992

Neurology · 245d

Cleared Oct 25, 1991

BIO TENS 601, 606 AND 608 (3000)

Neurology · 162d