The following data is part of a premarket notification filed by Hanuri Distribution, Inc with the FDA for Powerpress Recovery Unit.
Device ID | K202044 |
510k Number | K202044 |
Device Name: | Powerpress Recovery Unit |
Classification | Massager, Powered Inflatable Tube |
Applicant | Hanuri Distribution, Inc 9601 Owensmouth Ave. # 8 Chatsworth, CA 91311 |
Contact | Jung Hyun Moon |
Correspondent | Jung Hyun Moon Hanuri Distribution, Inc 9601 Owensmouth Ave. # 8 Chatsworth, CA 91311 |
Product Code | IRP |
CFR Regulation Number | 890.5650 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-07-23 |
Decision Date | 2020-10-21 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
POWERPRESS RECOVERY UNIT 90498431 not registered Live/Pending |
HANURI DISTRIBUTION, INC 2021-01-29 |