Skylark Device Co., Ltd.

Taipei, Taiwan, R.O.C., TW

Skylark Device Co., Ltd. appears in FDA device records in Taipei, Taiwan, R.O.C., TW. FDA records list 20 510(k) clearances between 1991-10-25 and 1999-10-27, no PMA records and no registered establishments. As of 2026-09-10, FDA records show no recalls for this company.

510(k) clearances: 20
PMA records: 0
Recall records: 0
Registered establishments: 0

510(k) clearance history

FDA records hold 20 510(k) clearances for Skylark Device Co., Ltd. between 1991 and 1999. The busiest year on record is 1992, with 4. The most recent is 1999, with 2.

Clearances by year, as a table

510(k) clearance decisions for Skylark Device Co., Ltd., by decision year
Year	Clearances
1991	2
1992	4
1993	1
1994	3
1995	2
1997	2
1998	4
1999	2

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K990233	ST-302 INFRAREX	ILY	Substantially Equivalent	1999-10-27
K984506	SD-100 SKYEAR THERMOMETER	FLL	Substantially Equivalent	1999-07-29
K981449	SD-956 ULTRASOUND THERAPY	IMI	Substantially Equivalent	1998-12-11
K983964	BATCH #6060 CONDUCTIVE GEL	GYB	Substantially Equivalent	1998-12-09
K964437	GB-1002 TENS WITH MASSAGE	GZJ	Substantially Equivalent	1998-08-14
K974585	IF-727 INTERFERENTIAL STIMULATOR	LIH	Substantially Equivalent	1998-03-06
K964434	SD-970EMS ELECTRICAL MUSCULAR STIMULATOR	IPF	Substantially Equivalent	1997-10-09
K963729	SD-610M(ALSO KNOWN AS STANDARD TENS, SD-609M,SD-611M, GLC-I STANDARD)	GZJ	Substantially Equivalent	1997-02-13
K946337	IT-727 (ALSO KNOWN AS IT-610, IT-600 AND DYNAPHOR II	EGJ	Substantially Equivalent	1995-12-20
K946299	PGS123 AND HVS-123	GZJ	Substantially Equivalent	1995-06-26
K934051	BIO SDP (AKA SATURN SD, GLC-III SD & STAT-SD)	GZJ	Substantially Equivalent	1994-07-11
K930535	IF400	LIH	Substantially Equivalent	1994-06-14
K931079	STAT-TENS	GZJ	Substantially Equivalent	1994-06-09
K925729	SD-602 SD MODE 11, SD-603 SD MOD 111	GZJ	Substantially Equivalent	1993-01-22
K923934	TX-3 SD	GZJ	Substantially Equivalent	1992-10-23
K923935	SD-605 SD II PROGRAM	GZJ	Substantially Equivalent	1992-10-15
K923298	MICRO 100,200,300, & 400 TENS	GZJ	Substantially Equivalent	1992-10-13
K912643	ELECTRODE	GXY	Substantially Equivalent	1992-02-14
K912642	EMS300, EMS400, EMS8000	IPF	Substantially Equivalent	1991-12-09
K912178	BIO TENS 601, 606 AND 608 (3000)	GZJ	Substantially Equivalent	1991-10-25

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain