The following data is part of a premarket notification filed by Drtv Asia Ltd with the FDA for Dr-ho's Foot Pad Electrode.
Device ID | K151693 |
510k Number | K151693 |
Device Name: | Dr-Ho's Foot Pad Electrode |
Classification | Electrode, Cutaneous |
Applicant | DRTV ASIA LTD 2ND BUILDING, JUNTUO INDUSTRY PARK, XINYE DADAO, NANCUN Panyu, CN 511442 |
Contact | Michael Ho |
Correspondent | Guenter Ginsberg MEDIA TRADE CORPORATION 11820 RED HIBISCUS DRIVE Bonita Springs, FL 34135 |
Product Code | GXY |
CFR Regulation Number | 882.1320 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-06-23 |
Decision Date | 2015-10-09 |
Summary: | summary |