Device Classification Name |
massager, powered inflatable tube
|
510(k) Number |
K211460 |
Device Name |
Air Relax Plus Model AR-3.0 |
Applicant |
Diode Art Engineering doing business as Air Relax |
9535 Brasher St |
Pico Rivera,
CA
90660
|
|
Applicant Contact |
Beomjoon Lee |
Correspondent |
REGULATORY TECHNOLOGY SERVICES, LLC |
1000 Westgate Drive, |
Suite 510k |
Saint Paul,
MN
55114
|
|
Correspondent Contact |
Prithul Bom |
Regulation Number | 890.5650
|
Classification Product Code |
|
Date Received | 05/11/2021 |
Decision Date | 05/25/2021 |
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
|
|
|