Skylark Device Co., Ltd. is one of 203 FDA 510(k) medical device manufacturers from Taiwan in the dataset, ranked by real submission volume.
Skylark Device Co., Ltd. - FDA 510(k) Cleared Devices
20
Total
20
Cleared
0
Denied
Skylark Device Co., Ltd. has 20 FDA 510(k) cleared neurology devices. Based in Taipei, Taiwan, R.O.C., TW.
Historical record: 20 cleared submissions from 1991 to 1999.
Browse the complete list of FDA 510(k) cleared neurology devices from this manufacturer. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Skylark Device Co., Ltd.
20 devices
Cleared
Oct 27, 1999
ST-302 INFRAREX
Physical Medicine
275d
Cleared
Jul 29, 1999
SD-100 SKYEAR THERMOMETER
General Hospital
223d
Cleared
Dec 11, 1998
SD-956 ULTRASOUND THERAPY
Physical Medicine
233d
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
Oct 09, 1997
SD-970EMS ELECTRICAL MUSCULAR STIMULATOR
Physical Medicine
338d
Cleared
Feb 13, 1997
SD-610M(ALSO KNOWN AS STANDARD TENS, SD-609M,SD-611M, GLC-I STANDARD)
Neurology
150d
Cleared
Dec 20, 1995
IT-727 (ALSO KNOWN AS IT-610, IT-600 AND DYNAPHOR II
Physical Medicine
356d
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
Cleared
Feb 14, 1992
ELECTRODE
Neurology
245d
Cleared
Dec 09, 1991
EMS300, EMS400, EMS8000
Physical Medicine
178d
Cleared
Oct 25, 1991
BIO TENS 601, 606 AND 608 (3000)
Neurology
162d