Company ยท TW
Skylark Device Co., Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 1991 to 1999. Name variants (Inc, Corp, punctuation) are merged.
20510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | 10 |
| IPF | Stimulator, Muscle, Powered | 2 |
| LIH | Interferential Current Therapy | 2 |
| EGJ | Device, Iontophoresis, Other Uses | 1 |
| FLL | Continuous Measurement Thermometer | 1 |
| GXY | Electrode, Cutaneous | 1 |
| GYB | Media, Electroconductive | 1 |
| ILY | Lamp, Infrared, Therapeutic Heating | 1 |
| IMI | Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 27, 1999 | K990233 | ST-302 INFRAREX Skylark Device Co., Ltd., TW | ILY |
| Jul 29, 1999 | K984506 | SD-100 SKYEAR THERMOMETER Skylark Device Co., Ltd., TW | FLL |
| Dec 11, 1998 | K981449 | SD-956 ULTRASOUND THERAPY Skylark Device Co., Ltd., TW | IMI |
| Dec 9, 1998 | K983964 | BATCH #6060 CONDUCTIVE GEL Skylark Device Co., Ltd., TW | GYB |
| Aug 14, 1998 | K964437 | GB-1002 TENS WITH MASSAGE Skylark Device Co., Ltd., TW | GZJ |
| Mar 6, 1998 | K974585 | IF-727 INTERFERENTIAL STIMULATOR Skylark Device Co., Ltd., TW | LIH |
| Oct 9, 1997 | K964434 | SD-970EMS ELECTRICAL MUSCULAR STIMULATOR Skylark Device Co., Ltd., TW | IPF |
| Feb 13, 1997 | K963729 | SD-610M(ALSO KNOWN AS STANDARD TENS, SD-609M,SD-611M, GLC-I STANDARD) Skylark Device Co., Ltd., TW | GZJ |
| Dec 20, 1995 | K946337 | IT-727 (ALSO KNOWN AS IT-610, IT-600 AND DYNAPHOR II Skylark Device Co., Ltd., TW | EGJ |
| Jun 26, 1995 | K946299 | PGS123 AND HVS-123 Skylark Device Co., Ltd., TW | GZJ |
| Jul 11, 1994 | K934051 | BIO SDP (AKA SATURN SD, GLC-III SD & STAT-SD) Skylark Device Co., Ltd., TW | GZJ |
| Jun 14, 1994 | K930535 | IF400 Skylark Device Co., Ltd., TW | LIH |
| Jun 9, 1994 | K931079 | STAT-TENS Skylark Device Co., Ltd., TW | GZJ |
| Jan 22, 1993 | K925729 | SD-602 SD MODE 11, SD-603 SD MOD 111 Skylark Device Co., Ltd., TW | GZJ |
| Oct 23, 1992 | K923934 | TX-3 SD Skylark Device Co., Ltd., TW | GZJ |
| Oct 15, 1992 | K923935 | SD-605 SD II PROGRAM Skylark Device Co., Ltd., TW | GZJ |
| Oct 13, 1992 | K923298 | MICRO 100,200,300, & 400 TENS Skylark Device Co., Ltd., TW | GZJ |
| Feb 14, 1992 | K912643 | ELECTRODE Skylark Device Co., Ltd., TW | GXY |
| Dec 9, 1991 | K912642 | EMS300, EMS400, EMS8000 Skylark Device Co., Ltd., TW | IPF |
| Oct 25, 1991 | K912178 | BIO TENS 601, 606 AND 608 (3000) Skylark Device Co., Ltd., TW | GZJ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||