The following data is part of a premarket notification filed by Xiamen High Top Electronic Technology Co., Ltd. with the FDA for Air Compression Leg Massager Hy-1117a.
Device ID | K212713 |
510k Number | K212713 |
Device Name: | Air Compression Leg Massager HY-1117A |
Classification | Massager, Powered Inflatable Tube |
Applicant | Xiamen High Top Electronic Technology Co., Ltd. F2-5 No. 118 Siming Park, Tong'an Industrial Zone Xiamen, CN 361000 |
Contact | Liangsan Zhao |
Correspondent | Sam Lin Shanghai Spica Management Consulting Co., Ltd. 609 Room, No.133 Shengang Avenue, Pudong New District Shanghai, CN 201306 |
Product Code | IRP |
CFR Regulation Number | 890.5650 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-08-26 |
Decision Date | 2022-01-18 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10850023727074 | K212713 | 000 |
10850023727050 | K212713 | 000 |
10850023727043 | K212713 | 000 |
10850023727036 | K212713 | 000 |