Medical Device Manufacturer · CN , Dongyang

Zhejiang Innuovo Rehabilitation Devices Co.,Ltd - FDA 510(k) Cleared ...

18 submissions · 18 cleared · Since 2022

Recent clearances: Power Wheelchair (N5515A, N5516, N5517A, N5519), Power Wheelchair (N5919 series), Power Wheelchair (W5538)

18
Total
18
Cleared
0
Denied

FDA 510(k) Regulatory Record - Zhejiang Innuovo Rehabilitation Devices Co.,Ltd Physical Medicine

18 devices
1-18 of 18
Cleared Jun 18, 2026
Power Wheelchair (W5915B, W5915C, W5915D)
K253812 · ITI
Physical Medicine · 202d
Cleared Jun 05, 2026
Power Wheelchair (N5515A, N5516, N5517A, N5519)
K260056 · ITI
Physical Medicine · 148d
Cleared Apr 20, 2026
Power Wheelchair (N5919 series)
K253806 · ITI
Physical Medicine · 143d
Cleared Nov 18, 2024
Power Wheelchair (W5538)
K242471 · ITI
Physical Medicine · 90d
Cleared Oct 11, 2024
Mobility Scooter (N3473)
K242387 · INI
Physical Medicine · 60d
Cleared Sep 10, 2024
Mobility Scooter
K240990 · INI
Physical Medicine · 152d
Cleared Jun 05, 2024
Mobility Scooter (W3331)
K240008 · INI
Physical Medicine · 155d
Cleared May 02, 2024
Mobility Scooter (W3431)
K240012 · INI
Physical Medicine · 121d
Cleared Dec 13, 2023
Power Wheelchair (N5909)
K230964 · ITI
Physical Medicine · 252d
Cleared Nov 09, 2023
Power Wheelchair, W5521
K231508 · ITI
Physical Medicine · 168d
Cleared Jul 14, 2023
Mobility Scooter (Models: W3431D)
K231428 · INI
Physical Medicine · 58d
Cleared Feb 28, 2023
Mobility Scooter (Models: W3431Q, W3431R)
K222507 · INI
Physical Medicine · 194d
Cleared Oct 17, 2022
Mobility Scooter, Model: W3331F
K222495 · INI
Physical Medicine · 60d
Cleared Jul 01, 2022
Power Wheelchair
K221026 · ITI
Physical Medicine · 86d
Cleared May 12, 2022
Power Wheelchair, W5907 (Q50 R Carbon)
K220740 · ITI
Physical Medicine · 59d
Cleared May 12, 2022
Power Wheelchair (N5515B)
K220747 · ITI
Physical Medicine · 59d
Cleared Mar 24, 2022
Mobility Scooter
K220206 · INI
Physical Medicine · 58d
Cleared Mar 24, 2022
Mobility Scooter, Model W3468
K220207 · INI
Physical Medicine · 58d
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