FDA product code · Physical Medicine · Class 2
ITI: Wheelchair, Powered
ITI is FDA's product code for "Wheelchair, Powered": a Class 2 device classified under 21 CFR 890.3860, reviewed by the Physical Medicine panel.
510(k) review time for ITI
Across 147 510(k) clearances under ITI decided from 2018-01-01 to 2026-10-06, the median was 119 days from FDA receipt to decision. Half took between 78 and 209 days, and 80% were decided within 224 days. These are past clearances, not a forecast for a new submission.
| Fastest | 21 |
|---|---|
| 25th percentile | 78 |
| Median | 119 |
| 75th percentile | 209 |
| 80th percentile | 224 |
| 90th percentile | 259 |
| Slowest | 1,155 |
| Year | Median days | n |
|---|---|---|
| 2020 | 278 | 6 |
| 2021 | 209 | 13 |
| 2022 | 96 | 16 |
| 2023 | 128 | 8 |
| 2024 | 125 | 38 |
| 2025 | 90 | 29 |
| 2026 (to 10-06, partial) | 108 | 30 |
Source: openFDA 510(k) records, snapshot of 2026-10-06 (openFDA data as of 2026-09-28). Compare 510(k) review times across all device types, see every code side by side in the Clearance Timeline Estimator, or browse the clearances themselves in PredicateScope.
ITI in the public FDA record
| 510(k) clearances, all years | 586 |
|---|---|
| Device recalls | 71 |
| Establishment listings | 359 |
| GUDID device identifiers | 1,433 |
Counts of records, not of devices or events. Adverse event reports for ITI are in MAUDEScope, as counts with the query shown: MAUDE has no denominator, so a report count is not a rate and does not show that a device caused an event.
FDA-recognized standards that cite ITI
43 FDA recognized consensus standards cite ITI, 1 of them recognized only in part, among them ISO 7176-4 Third edition 2008-10-01; ISO 7176-5 Second edition 2008-06-01; ISO 7176-10 Second edition 2008-11-01. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 16-162 ISO 7176-4 Third edition 2008-10-01 — Wheelchairs - Part 4: Energy consumption of electric wheelchairs and scooters for determination of theoretical distance range
- 16-163 ISO 7176-5 Second edition 2008-06-01 — Wheelchairs - Part 5: Determination of overall dimensions mass and manoeuvring space
- 16-164 ISO 7176-10 Second edition 2008-11-01 — Wheelchairs - Part 10: Determination of obstacle-climbing ability of electrically powered wheelchairs
- 16-166 ISO 7176-21 Second edition 2009-04-01 (partial recognition) — Wheelchairs - Part 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters and battery chargers
- 16-167 ISO 7176-9 Third edition 2009-11-15 — Wheelchairs - Part 9: Climatic tests for electric wheelchairs
- 16-190 ISO 7176-11 Second edition 2012-12-01 — Wheelchairs - Part 11: Test dummies
- 16-192 ISO 7176-3 Third edition 2012-12-15 — Wheelchairs - Part 3: Determination of effectiveness of brakes
- 16-195 ISO 7176-1 Third edition 2014-10-01 — Wheelchairs - Part 1: Determination of static stability
- 16-196 ISO 7176-7 First Edition 1998-05-15 — Wheelchairs - Part 7: Measurement of seating and wheel dimensions
- 16-197 ISO 7176-8 Second editon 2014-12-15 — Wheelchairs - Part 8: Requirements and test methods for static impact and fatigue strengths
- 16-198 ISO 7176-22 Second edition 2014-09-01 — Wheelchairs - Part 22: Set-up procedures
- 16-202 ISO 7176-2 Third edition 2017-10 — Wheelchairs - Part 2:Determination of dynamic stability of electrically powered wheelchairs
- 16-203 ASME A18.1-2017 — Safety Standard for Platform Lifts and Stairway Chairlifts
- 16-204 ISO 7176-6 Third edition 2018-06 — Wheelchairs - Part 6: Determination of maximum speed of electrically powered wheelchairs
- 16-206 ISO 7176 - 30 First edition 2018-12 — Wheelchairs --Part 30: Wheelchairs for changing occupant posture --Test methods and requirements
The first 15 of 43 are shown. Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.