Device Classification Name |
massager, powered inflatable tube
|
510(k) Number |
K211283 |
Device Name |
Compressible Limb and Circulation Therapy System, Model POWER-Q2300 |
Applicant |
Wonjin Mulsan Co., Ltd. |
89, Geomdan-ro, Seo-gu |
Incheon,
KR
22653
|
|
Applicant Contact |
Ha Yong Jung |
Correspondent |
Wonjin Mulsan Co., Ltd. |
89, Geomdan-ro, Seo-gu |
Incheon,
KR
22653
|
|
Correspondent Contact |
Ha Yong Jung |
Regulation Number | 890.5650
|
Classification Product Code |
|
Date Received | 04/27/2021 |
Decision Date | 09/14/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Physical Medicine
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|