Device Classification Name |
Stimulator, Nerve, Transcutaneous, Over-The-Counter
|
510(k) Number |
K063660 |
Device Name |
OTC TENS FOR LOW BACK PAIN RELIEF, MODEL WL-2407 |
Applicant |
WELL-LIFE HEALTHCARE LIMITED |
68 MODY ROAD |
TSIMSHATSUIM |
KOWLOON,
HK
|
|
Applicant Contact |
JENNY HSIEH |
Correspondent |
WELL-LIFE HEALTHCARE LIMITED |
68 MODY ROAD |
TSIMSHATSUIM |
KOWLOON,
HK
|
|
Correspondent Contact |
JENNY HSIEH |
Regulation Number | 882.5890
|
Classification Product Code |
|
Date Received | 12/08/2006 |
Decision Date | 02/07/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|