FDA 510(k) Applications Submitted by Grace Li
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K240008 |
01/02/2024 |
Mobility Scooter (W3331) |
Zhejiang Innuovo Rehabilitation Devices Co.,Ltd |
| K240012 |
01/02/2024 |
Mobility Scooter (W3431) |
Zhejiang Innuovo Rehabilitation Devices Co., Ltd. |
| K140201 |
01/27/2014 |
AXERA 2 ACCESS SYSTEM |
ARSTASIS, INC. |
| K140287 |
02/05/2014 |
AXERA RX ACCESS SYSTEM |
ARSTASIS, INC. |
| K160681 |
03/10/2016 |
CenterCross Ultra Catheter |
ROXWOOD MEDICAL, INC |
| K140871 |
04/04/2014 |
AXERA 2 ACCESS SYSTEM |
ARSTASIS, INC. |
| K230964 |
04/05/2023 |
Power Wheelchair (N5909) |
Zhejiang Innuovo Rehabilitation Devices Co., Ltd. |
| K240990 |
04/11/2024 |
Mobility Scooter |
Zhejiang Innuovo Rehabilitation Devices Co.,Ltd. |
| K151082 |
04/22/2015 |
MicroCross Catheter |
ROXWOOD MEDICAL, INC. |
| K231428 |
05/17/2023 |
Mobility Scooter (Models: W3431D) |
Zhejiang Innuovo Rehabilitation Devices Co.,Ltd |
| K231508 |
05/25/2023 |
Power Wheelchair, W5521 |
Zhejiang Innuovo Rehabilitation Devices Co., Ltd. |
| K152456 |
08/28/2015 |
CenterCross Ultra Catheter |
ROXWOOD MEDICAL, INC. |
| K232789 |
09/11/2023 |
VIO System (V-1000) |
Enspectra Health, Inc. |
| K152957 |
10/07/2015 |
MultiCross Catheter |
ROXWOOD MEDICAL, INC. |
| K143744 |
12/31/2014 |
MicroCross Catheter |
ROXWOOD MEDICAL, INC. |
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