Shanghai Hubang Intelligent Rehabilitation Equipment Co.,Ltd FDA Record
- Latest inspection VAI · Sep 4, 2025
- No warning letters matched by name
Shanghai Hubang Intelligent Rehabilitation Equipment Co.,Ltd has 0 FDA recalls, 1 inspection, 1 510(k) clearance and 0 compliance actions on record. No FDA warning letter addressed to "Shanghai Hubang Intelligent Rehabilitation Equipment Co.,Ltd" is on file.
- Latest inspection
- Sep 4, 2025 · VAI
- Latest 510(k)
- May 31, 2024
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 11, 2026 (checked Nov 15, 2026, unchanged) | File dated Nov 10, 2026 | Current |
| 510(k) clearances | 1 | Nov 15, 2026 | File dated Nov 9, 2026 | Current |
| Inspections | 1 | Nov 15, 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 |
|---|---|---|---|---|
| Sep 4, 2025 | Shanghai, China | Devices | Voluntary Action Indicated (VAI) | 3030410174 |
- 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 3030410174 | Shanghai, China | 1 | Sep 4, 2025 |
Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K240913 | Electric Wheelchair (HBLD3-B); Electric Wheelchair (HBLD3-E) | May 31, 2024 |
Shanghai Hubang Intelligent Rehabilitation Equipment Co.,Ltd and the FDA: common questions
Has Shanghai Hubang Intelligent Rehabilitation Equipment Co.,Ltd received an FDA warning letter?
No FDA warning letter addressed to the name "Shanghai Hubang Intelligent Rehabilitation Equipment 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 Shanghai Hubang Intelligent Rehabilitation Equipment Co.,Ltd received an FDA Form 483?
FDA has not published a Form 483 for "Shanghai Hubang Intelligent Rehabilitation Equipment Co.,Ltd" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Shanghai Hubang Intelligent Rehabilitation Equipment Co.,Ltd?
The most recent FDA inspection on file ended Sep 4, 2025 at Shanghai, China and was classified VAI. FDA has 1 inspection of Shanghai Hubang Intelligent Rehabilitation Equipment Co.,Ltd on file.
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