Device Classification Name |
Stimulator, Electro-Acupuncture
|
510(k) Number |
K200636 |
Device Name |
AXUS ES-5 Electro-Acupuncture Device |
Applicant |
Lhasa OMS, INC. |
230 Libbey Parkway |
Weymouth,
MA
02189
|
|
Applicant Contact |
Colleen Pike |
Correspondent |
Ken Block Consulting, LLC |
800 E. Campbell Road, Suite 202 |
Richardson,
TX
75081
|
|
Correspondent Contact |
Saori Sawaki |
Classification Product Code |
|
Date Received | 03/10/2020 |
Decision Date | 02/03/2021 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|