510(k) K033819
- Device
- INVACARE 3G TARSYS
- Applicant
- INVACARE CORP.
- 510(k) number
- K033819
- Product code
- ITI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2004-06-04
- Date received
- 2003-12-09
- Regulation
- 890.3860
- Classification name
- Wheelchair, Powered
- Medical specialty
- Physical Medicine
- Review panel
- Physical Medicine
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- CARROLL MARTIN
- Address
- One Invacare Way P.O. Box 4028 Elyria OH US 44035 44035
FDA Registration Numbers#
- 3016969129
- 3035853002
- 3039359026
- 3017278503
- 3020155847
- 3027135885
- 3020640553
- 2531465
- 3005260401
- 2027797
- 3026585646
- 8043717
- 3022159079
- 3015992762
- 3027344674
- 3012274425
- 3032014158
- 2648727
- 3033860076
- 3032587493
- 3011191255
- 3019984611
- 3007728095
- 3033848621
- 3030822491
- 3006160539
- 1531186
- 3005905321
- 3031588965
- 1058069
- 3044425292
- 3039857114
- 3021374638
- 3007309323
- 3043105518
- 3012538618
- 3003636180
- 3008597995
- 3012521614
- 3004730072
- 3030671633
- 9615410
- 3008370857
- 3003882673
- 3014266593
- 3004141004
- 3011707750
- 3005619729
- 9616873
- 3012425482
- 3014471045
- 3021959198
- 3009265647
- 3035111592
- 3010461764
- 3004594214
- 3035782854
- 3001185828
- 3014983822
- 3030226288
- 1821729
- 3014522447
- 3005783142
- 3008841035
- 3008466210
- 1220973
- 8043457
- 3004443928
- 3019842343
- 3003857817
- 9680333
- 3032171348
- 9616881
- 3003650116
- 3003123807
- 3014653196
- 3045076265
- 3043088974
- 3002667030
Source Documents#
Other 510(k) Records For Product Code ITI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261149 | Electric Wheelchair (DY611A-2, DY612A-1) | Zhejiang Lumbre Electric Appliance Co., Ltd. | 2026-07-10 |
| K261396 | Electric Wheelchair | Ningbo Resshidi Medical Devices Co., Ltd. | 2026-07-08 |
| K261164 | Electric wheelchair (XW-LY007 ) | Yongkang Ruihe Metal Product Co., Ltd. | 2026-07-07 |
| K260937 | Smart Electric Wheelchair (R1-Std-BK, R1-Pro-BK, R1-Ultra-GK, R1-Ultra-WK) | Shanghai Waylong Intelligent Technology Co.,Ltd | 2026-06-24 |
| K253812 | Power Wheelchair (W5915B, W5915C, W5915D) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 2026-06-18 |
| K260335 | Electric Wheelchair (S500-6) | Zhongshan Sulenz Intelligent Technology Co., Ltd. | 2026-06-15 |
| K261175 | WHILL (WHILL Model C2) | Whill, Inc. | 2026-06-12 |
| K260056 | Power Wheelchair (N5515A, N5516, N5517A, N5519) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 2026-06-05 |
| K260373 | Electric Wheelchair (DF506) | Jiangsu Yveelt Medical Equipment Co., Ltd. | 2026-06-03 |
| K253241 | Electric Wheelchair (Y207BL) | Jiangsu Intco Medical Products Co., Ltd. | 2026-05-13 |
| K253806 | Power Wheelchair (N5919 series) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 2026-04-20 |
| K253952 | Power Wheelchair (OS-R-M01S) | Beijing OrionStar Technology Co., Ltd. | 2026-04-07 |
| K253340 | Electric Wheelchair (AL-208S-063) | Zhongshan A&J Medical Equipment Co., Ltd. | 2026-04-03 |
| K253307 | Electric wheelchair | Foshan Dahao Medical Technology Co., Ltd. | 2026-03-27 |
| K253980 | Electrically Powered Wheelchair (Model YC-01) | Yurob Rehabilitation Medical Co., Ltd. | 2026-03-27 |
Legacy Summary#
summary
FDA Review#
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