K191862 is an FDA 510(k) clearance for the Compression Therapy Device Model LGT-2200SP. This device is classified as a Massager, Powered Inflatable Tube (Class II - Special Controls, product code IRP).
Submitted by Guangzhou Longest Science & Technology Co., Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on October 29, 2019, 110 days after receiving the submission on July 11, 2019.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5650.
| 510(k) Number | K191862 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 11, 2019 |
| Decision Date | October 29, 2019 |
| Days to Decision | 110 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 |