K240358 is an FDA 510(k) clearance for the ShockPhysio Mobile (model SW3200 Basic). This device is classified as a Massager, Therapeutic, Electric (Class I - General Controls, product code ISA).
Submitted by Shenzhen Dongdixin Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on June 5, 2024, 120 days after receiving the submission on February 6, 2024.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5660.
| 510(k) Number | K240358 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 06, 2024 |
| Decision Date | June 05, 2024 |
| Days to Decision | 120 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Statement |
| Product Code | ISA — Massager, Therapeutic, Electric |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 890.5660 |