K210967 is an FDA 510(k) clearance for the Air Pressure Therapy System: VU-IPC06. This device is classified as a Massager, Powered Inflatable Tube (Class II - Special Controls, product code IRP).
Submitted by Xiamen Weiyou Intelligent Technology Co., Ltd. (Xiamen, CN). The FDA issued a Cleared decision on May 11, 2021, 41 days after receiving the submission on March 31, 2021.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5650.
| 510(k) Number | K210967 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 31, 2021 |
| Decision Date | May 11, 2021 |
| Days to Decision | 41 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | IRP - Massager, Powered Inflatable Tube |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5650 |