FDA 510(k) Applications Submitted by GEORGE K.C. CHEN

FDA 510(k) Number Submission Date Device Name Applicant
K964434 11/05/1996 SD-970EMS ELECTRICAL MUSCULAR STIMULATOR SKYLARK DEVICE CO., LTD.
K963729 09/16/1996 SD-610M(ALSO KNOWN AS STANDARD TENS, SD-609M,SD-611M, GLC-I STANDARD) SKYLARK DEVICE CO., LTD.
K983964 11/06/1998 BATCH #6060 CONDUCTIVE GEL SKYLARK DEVICE CO., LTD.
K981449 04/22/1998 SD-956 ULTRASOUND THERAPY SKYLARK DEVICE CO., LTD.
K984506 12/18/1998 SD-100 SKYEAR THERMOMETER SKYLARK DEVICE CO., LTD.
K964437 11/05/1996 GB-1002 TENS WITH MASSAGE SKYLARK DEVICE CO., LTD.
K990233 01/25/1999 ST-302 INFRAREX SKYLARK DEVICE CO., LTD.
K992652 08/06/1999 SD-730 IF-SDS, PERFECT PULSE IF-SDS SKYLARK DEVICE & SYSTEMS CO., LTD
K002832 09/11/2000 CONDUCTIVE GEL FOR ULTRASOUND SKYLARK DEVICE & SYSTEMS CO., LTD
K974585 12/08/1997 IF-727 INTERFERENTIAL STIMULATOR SKYLARK DEVICE CO., LTD.


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact