Zhejiang Innuovo Rehabilitation Devices Co.,Ltd FDA Record
- Latest inspection NAI · Jun 4, 2026
- No warning letters matched by name
Zhejiang Innuovo Rehabilitation Devices Co.,Ltd has 0 FDA recalls, 1 inspection, 20 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Zhejiang Innuovo Rehabilitation Devices Co.,Ltd" is on file.
- Latest inspection
- Jun 4, 2026 · NAI
- Latest 510(k)
- Aug 10, 2026
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 | 20 | 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 |
|---|---|---|---|---|
| Jun 4, 2026 | Jinhua, China | Devices | No Action Indicated (NAI) | 3012521614 |
- 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 3012521614 | Jinhua, China | 1 | Jun 4, 2026 |
Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K260094 | Mobility Scooter (W3465, W3902 (S50 Carbon)) | Aug 10, 2026 |
| K260176 | Mobility Scooter (W3483, W3483A) | Aug 10, 2026 |
| K253812 | Power Wheelchair (W5915B, W5915C, W5915D) | Jun 18, 2026 |
| K260056 | Power Wheelchair (N5515A, N5516, N5517A, N5519) | Jun 5, 2026 |
| K253806 | Power Wheelchair (N5919 series) | Apr 20, 2026 |
| K242471 | Power Wheelchair (W5538) | Nov 18, 2024 |
| K242387 | Mobility Scooter (N3473) | Oct 11, 2024 |
| K240990 | Mobility Scooter | Sep 10, 2024 |
| K240008 | Mobility Scooter (W3331) | Jun 5, 2024 |
| K240012 | Mobility Scooter (W3431) | May 2, 2024 |
| K230964 | Power Wheelchair (N5909) | Dec 13, 2023 |
| K231508 | Power Wheelchair, W5521 | Nov 9, 2023 |
| K231428 | Mobility Scooter (Models: W3431D) | Jul 14, 2023 |
| K222507 | Mobility Scooter (Models: W3431Q, W3431R) | Feb 28, 2023 |
| K222495 | Mobility Scooter, Model: W3331F | Oct 17, 2022 |
| K221026 | Power Wheelchair | Jul 1, 2022 |
| K220747 | Power Wheelchair (N5515B) | May 12, 2022 |
| K220740 | Power Wheelchair, W5907 (Q50 R Carbon) | May 12, 2022 |
| K220206 | Mobility Scooter | Mar 24, 2022 |
| K220207 | Mobility Scooter, Model W3468 | Mar 24, 2022 |
Zhejiang Innuovo Rehabilitation Devices Co.,Ltd and the FDA: common questions
Has Zhejiang Innuovo Rehabilitation Devices Co.,Ltd received an FDA warning letter?
No FDA warning letter addressed to the name "Zhejiang Innuovo Rehabilitation Devices 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 Zhejiang Innuovo Rehabilitation Devices Co.,Ltd received an FDA Form 483?
FDA has not published a Form 483 for "Zhejiang Innuovo Rehabilitation Devices Co.,Ltd" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Zhejiang Innuovo Rehabilitation Devices Co.,Ltd?
The most recent FDA inspection on file ended Jun 4, 2026 at Jinhua, China and was classified NAI. FDA has 1 inspection of Zhejiang Innuovo Rehabilitation Devices Co.,Ltd on file.
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