Shenzhen Osto Technology Company Limited
Shenzhen Osto Technology Company Limited has 0 FDA recalls, 1 inspection, 12 510(k) clearances and 0 compliance actions on record.
- Latest inspection
- Mar 18, 2025 · VAI
- Latest 510(k)
- Jul 7, 2022
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Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Oct 23, 2026 | Not stated | Current |
| 510(k) clearances | 12 | Oct 4, 2026 | Not stated | Current |
| Inspections | 1 | Oct 23, 2026 | Not stated | Current |
| Compliance actions | 0 | Oct 23, 2026 | Not stated | Current |
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Mar 18, 2025 | Shenzhen, China | Devices | Voluntary Action Indicated (VAI) | 3011564440 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K213056 | LED Facial Mask | Jul 7, 2022 |
| K211942 | Heating Lumbar Therapy Cushion (Model: AST-622, AST-622B, AST-623, AST-623B) | Dec 13, 2021 |
| K212989 | Low-frequency Stimulator (Model: AST-645, AST-646) | Nov 22, 2021 |
| K211736 | Electronic Muscle Stimulator (Model: AST-300A, AST-300N, AST-300S, AST-300T, AST-300V, AST-300W) | Sep 5, 2021 |
| K210756 | Neck Care Therapy, Model: AST-905A, AST-905D, AST-905H | Jun 11, 2021 |
| K190783 | Health Expert Electronic Stimulator (model: AST-300L) | Mar 14, 2020 |
| K190673 | Health Expert Electronic Stimulator | Dec 12, 2019 |
| K182136 | Intelligent Wireless Fitness Apparatus (Model: AST-301, AST-302, AST-303) | Oct 10, 2019 |
| K172897 | Neck Care Therapy, Model: SYK 509B | Dec 7, 2018 |
| K172837 | Low-frequency Multi-function physiotherapy instrument | Nov 26, 2018 |
| K172834 | Dual output digital therapy massager | Sep 6, 2018 |
| K133929 | HEALTH EXPERT ELCTRONIC STIMULATOR | Nov 12, 2014 |