Invacare® TDX® SP2 Power Wheelchair +1 more— 510(k) K170507
Substantially EquivalentInvacare Corporation
FDA 510(k) clearance K170507 for Invacare® TDX® SP2 Power Wheelchair +1 more, Substantially Equivalent on 2017-07-12. Applicant: Invacare Corporation. Device class: 2.
Clearance details
- Device name as filed
- Invacare® TDX® SP2 Power Wheelchair; TDXSP2 TDX SP2 with LiNX Electronics, TDXSP2-CG TDX SP2 Base for Single Act. System w/ Ultra Low Maxx, TDXSP2-MCG TDX SP2 Base for Multiple Actuator System w/ Ultra Low Maxx
- Applicant
- Invacare Corporation
- Product code
- Code ITI
- Device class
- Class 2
- Regulation
- 21 CFR 890.3860
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Elyria, OH, US
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Adverse events under product code ITI
product code ITI- Death
- 34
- Injury
- 778
- Malfunction
- 1,085
- Other
- 1
- Total
- 1,898
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K170507
K-number listed on FDA's recall record- Z-1130-2022 — Invacare TDX SP2, Model Nos. TDXSP2 TDXSP2-MCG TDXSP2V
- Z-0445-2022 — Invacare TDX SP2 with LiNX Gyro Power Wheelchair (with LiNX Gyro Module Model Numbers DLX-GRY100-A and DLX-GRY101-A) Models: TDX SP2: TDXSP2, TDXSP2-CG, TDXSP2X-CG, TDXSP2-MCG, TDXSP2X-MCG, TDXSP2V, TDXSP2V-HD, TDXSP2HD, TDXSP2HD-CG, TDXSP2HD-MCG
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K170507.
Data sourced from openFDA. This site is unofficial and independent of the FDA.