Device Classification Name |
Stimulator, Muscle, Powered
|
510(k) Number |
K100117 |
Device Name |
LT3000 COMBO STIMULATOR, LT3001 TENS STIMULATORY, LT3002 EMS STIMULATOR |
Applicant |
SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD. |
ESTAE XILIXIAOBAIMANG |
NANSHAN DISTRICT, SHENZHEN,
CN
518108
|
|
Applicant Contact |
ZHIGANG ZHAO |
Correspondent |
UNDERWRITERS LABORATORIES, INC. |
2600 NW LAKE RD. |
CAMAS,
WA
98607 -9526
|
|
Correspondent Contact |
MARC M MOUSER |
Regulation Number | 890.5850
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 01/15/2010 |
Decision Date | 01/29/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Physical Medicine
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|