Skylark Device Co., Ltd. - FDA 510(k) Cleared Devices
Recent clearances: ST-302 INFRAREX, SD-100 SKYEAR THERMOMETER, SD-956 ULTRASOUND THERAPY
20
Total
20
Cleared
0
Denied
FDA 510(k) Regulatory Record - Skylark Device Co., Ltd. Neurology ✕
14 devices
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
IF400
Neurology
497d
Cleared
Jun 09, 1994
STAT-TENS
Neurology
463d
Cleared
Jan 22, 1993
SD-602 SD MODE 11, SD-603 SD MOD 111
Neurology
70d
Cleared
Oct 23, 1992
TX-3 SD
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