Zhejiang Innuovo Rehabilitation Devices Co.,Ltd: FDA filings under this applicant name
FDA lists 20 510(k) clearances under the applicant name “Zhejiang Innuovo Rehabilitation Devices Co.,Ltd” (first 2022, latest 2026), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 132 days. Since 2017 the median was 132 days, against 126 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2022 | 6 | 59 |
| 2023 | 4 | 181 |
| 2024 | 5 | 121 |
| 2025 | 0 | — |
| 2026 | 5 | 201 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Zhejiang Innuovo Rehabilitation Devices Co.,Ltd took a median 132 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 126 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| INI | Vehicle, Motorized 3-Wheeled | 11 | 11 |
| ITI | Wheelchair, Powered | 9 | 9 |
Review panels
- Physical Medicine (20)
Most recent Zhejiang Innuovo Rehabilitation Devices Co.,Ltd 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260176 | Mobility Scooter (W3483, W3483A) | INI | 2026-08-10 | 201 |
| K260094 | Mobility Scooter (W3465, W3902 (S50 Carbon)) | INI | 2026-08-10 | 209 |
| K253812 | Power Wheelchair (W5915B, W5915C, W5915D) | ITI | 2026-06-18 | 202 |
| K260056 | Power Wheelchair (N5515A, N5516, N5517A, N5519) | ITI | 2026-06-05 | 148 |
| K253806 | Power Wheelchair (N5919 series) | ITI | 2026-04-20 | 143 |
| K242471 | Power Wheelchair (W5538) | ITI | 2024-11-18 | 90 |
| K242387 | Mobility Scooter (N3473) | INI | 2024-10-11 | 60 |
| K240990 | Mobility Scooter | INI | 2024-09-10 | 152 |
| K240008 | Mobility Scooter (W3331) | INI | 2024-06-05 | 155 |
| K240012 | Mobility Scooter (W3431) | INI | 2024-05-02 | 121 |
10 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Zhejiang Innuovo Rehabilitation Devices Co.,Ltd.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Zhejiang Chuangxiang Medical Technology Co., Ltd. (14 510(k)s)
- ZheJiang Decans Medical Devices Co., Ltd. (11 510(k)s)
- Zhejiang Curaway Medical Technology Co., Ltd. (7 510(k)s)
- Zhejiang Kindly Medical Devices Co., Ltd. (5 510(k)s)
- Zhejiang Longterm Medical Technology Co., Ltd. (5 510(k)s)
- Zhejiang Soudon Medical Technology Co., Ltd. (5 510(k)s)
- Zhejiang Kangkang Medical-Devices Co., Ltd. (4 510(k)s)
- Zhejiang Nysin Medical Co., Ltd. (4 510(k)s)
- Zhejiang Gongdong Medical Technology Co., Ltd. (3 510(k)s)
- Zhejiang Zhonglei Medical Technology Co. , Ltd. (3 510(k)s)
- Zhejiang Carebao Co., Ltd. (2 510(k)s)
- Zhejiang Geyi Medical Instrument Co., Ltd. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Zhejiang Innuovo Rehabilitation Devices Co.,Ltd?
FDA lists 20 510(k) clearances under the applicant name “Zhejiang Innuovo Rehabilitation Devices Co.,Ltd” (first 2022, latest 2026), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Zhejiang Innuovo Rehabilitation Devices Co.,Ltd?
The median time from FDA receipt to decision across 510(k)s cleared under the name Zhejiang Innuovo Rehabilitation Devices Co.,Ltd is 132 days. Since 2017: 132 days, versus 126 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Zhejiang Innuovo Rehabilitation Devices Co.,Ltd?
The most frequent FDA product codes under this applicant name are INI (Vehicle, Motorized 3-Wheeled, 11); ITI (Wheelchair, Powered, 9).
Next steps
- See all 20 Zhejiang Innuovo Rehabilitation Devices Co.,Ltd clearances with predicates and recalls
- Run predicate analysis for product code INI, Zhejiang Innuovo Rehabilitation Devices Co.,Ltd's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.