Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Zhejiang Innuovo Rehabilitation Devices Co.,Ltd · Predicate Candidate Screening
18 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
121 daysmedian FDA review time
202 days90th percentile
18clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253812 | Power Wheelchair (W5915B, W5915C, W5915D) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 2026-06-18 | 202 | 0 |
| K260056 | Power Wheelchair (N5515A, N5516, N5517A, N5519) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 2026-06-05 | 148 | 0 |
| K253806 | Power Wheelchair (N5919 series) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 2026-04-20 | 143 | 0 |
| K242471 | Power Wheelchair (W5538) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 2024-11-18 | 90 | 0 |
| K242387 | Mobility Scooter (N3473) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 2024-10-11 | 60 | 0 |
| K240990 | Mobility Scooter | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 2024-09-10 | 152 | 0 |
| K240008 | Mobility Scooter (W3331) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 2024-06-05 | 155 | 0 |
| K240012 | Mobility Scooter (W3431) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 2024-05-02 | 121 | 0 |
| K230964 | Power Wheelchair (N5909) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 2023-12-13 | 252 | 0 |
| K231508 | Power Wheelchair, W5521 | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 2023-11-09 | 168 | 0 |
| K231428 | Mobility Scooter (Models: W3431D) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 2023-07-14 | 58 | 0 |
| K222507 | Mobility Scooter (Models: W3431Q, W3431R) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 2023-02-28 | 194 | 0 |
| K222495 | Mobility Scooter, Model: W3331F | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 2022-10-17 | 60 | 0 |
| K221026 | Power Wheelchair | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 2022-07-01 | 86 | 0 |
| K220740 | Power Wheelchair, W5907 (Q50 R Carbon) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 2022-05-12 | 59 | 0 |
| K220747 | Power Wheelchair (N5515B) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 2022-05-12 | 59 | 0 |
| K220206 | Mobility Scooter | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 2022-03-24 | 58 | 0 |
| K220207 | Mobility Scooter, Model W3468 | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 2022-03-24 | 58 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda