Shenzhen Osto Medical Technology Co.,Ltd FDA Record
Shenzhen Osto Medical Technology Co.,Ltd has 0 FDA recalls, 1 inspection, 1 510(k) clearance and 0 compliance actions on record. No FDA warning letter addressed to "Shenzhen Osto Medical Technology Co.,Ltd" is on file.
- Latest inspection
- Mar 20, 2025 · VAI
- Latest 510(k)
- Sep 6, 2026
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 1 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 1 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Mar 20, 2025 | Huizhou, China | Devices | Voluntary Action Indicated (VAI) | 3033773102 |
- NAI
- No objectionable conditions or practices were found during the inspection.
- VAI
- Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
- OAI
- Regulatory and/or administrative actions are recommended.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3033773102 | Huizhou, China | 1 | Mar 20, 2025 |
Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K261131 | Electrical Muscle Stimulator (AST-105DJ, AST-105EJ, AST- 105BJ, AST-105GJ, AST-303J, AST-309J… | Sep 6, 2026 |
Shenzhen Osto Medical Technology Co.,Ltd and the FDA: common questions
Has Shenzhen Osto Medical Technology Co.,Ltd received an FDA warning letter?
No FDA warning letter addressed to the name "Shenzhen Osto Medical Technology Co.,Ltd" is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has Shenzhen Osto Medical Technology Co.,Ltd received an FDA Form 483?
FDA has not published a Form 483 for "Shenzhen Osto Medical Technology Co.,Ltd" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Shenzhen Osto Medical Technology Co.,Ltd?
The most recent FDA inspection on file ended Mar 20, 2025 at Huizhou, China and was classified VAI. FDA has 1 inspection of Shenzhen Osto Medical Technology Co.,Ltd on file.
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