# Zhejiang Innuovo Rehabilitation Devices Co.,Ltd

- Location (FDA's records): Dongyang, CN
- FDA decisions: 20 (2022–2026): 20 510(k) clearances
- Product codes: INI (11), ITI (9)
- 510(k) review time since 2016: median 132 days, against 124 for FDA's reviews in the same codes and years (10 of 20 faster)
- Predicates its devices cite: 14 (8 its own); citations of its devices by later devices: 38 (8 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Suzhou KD Medical Appliance Co., Ltd.: 2 (https://510kreport.com/company/suzhou-kd-medical-appliance)
- Tianjin Kepler Vehicle Industry Co., Ltd.: 2 (https://510kreport.com/company/tianjin-kepler-vehicle-industry)
- Jiangsu Intco Medical Products Co., Ltd.: 1 (https://510kreport.com/company/jiangsu-intco-medical-products)
- Nanjing Jin Bai HE Medical Apparatus Co., Ltd.: 1 (https://510kreport.com/company/nanjing-jin-bai-he-medical-apparatus)

## Firms that cite its devices most
- Zhejiang Zhonglei Medical Technology Co., Ltd.: 2 (https://510kreport.com/company/zhejiang-zhonglei-medical-technology)
- Suzhou Master Machinery Manufacturing Co.,Ltd: 2 (https://510kreport.com/company/suzhou-master-machinery-manufacturing)
- Nanjing Kangni Smart Technology Co., Ltd.: 2 (https://510kreport.com/company/nanjing-kangni-smart-technology)
- Ningbo Baichen Medical Devices Co., Ltd.: 2 (https://510kreport.com/company/ningbo-baichen-medical-devices)
- Kunshan Hi-Fortune Health Products Co., Ltd.: 2 (https://510kreport.com/company/kunshan-hi-fortune-health-products)
- Zhejiang Hfizer Medical Equipment Co., Ltd.: 1 (https://510kreport.com/company/zhejiang-hfizer-medical-equipment)
- Zhejiang Jianrui Technology Company Limited: 1 (https://510kreport.com/company/zhejiang-jianrui-technology)
- Zhe Jiang Cleisman Industry and Trade Co.,Ltd: 1 (https://510kreport.com/company/zhe-jiang-cleisman-industry-and-trade)

## Its most-cited devices
- K220747: Power Wheelchair (N5515B) (2022), cited by 12
- K231428: Mobility Scooter (Models: W3431D) (2023), cited by 5
- K231508: Power Wheelchair, W5521 (2023), cited by 5
- K230964: Power Wheelchair (N5909) (2023), cited by 5
- K222495: Mobility Scooter, Model: W3331F (2022), cited by 2
- K220206: Mobility Scooter (2022), cited by 2

## Recent decisions
- K260176: Mobility Scooter (W3483, W3483A) (Aug 10, 2026)
- K260094: Mobility Scooter (W3465, W3902 (S50 Carbon)) (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)

Source page: https://510kreport.com/company/zhejiang-innuovo-rehabilitation-devices