K213000 is an FDA 510(k) clearance for the Air Compression Massager (Model LF-FT003). This device is classified as a Massager, Powered Inflatable Tube (Class II - Special Controls, product code IRP).
Submitted by Wenzhou Lingfeng Electronic Technology Co., Ltd. (Ruian, CN). The FDA issued a Cleared decision on November 15, 2021, 56 days after receiving the submission on September 20, 2021.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5650.
| 510(k) Number | K213000 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 20, 2021 |
| Decision Date | November 15, 2021 |
| Days to Decision | 56 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Statement |
| Product Code | IRP - Massager, Powered Inflatable Tube |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5650 |