DAKOTA MODEL 102C WHEELCHAIR— 510(k) K870297

Name: FDA 510(k) clearance K870297
Creator: U.S. Food and Drug Administration
Published: 1987-02-10

Substantially Equivalent

Redman, Inc.

FDA 510(k) clearance K870297 for DAKOTA MODEL 102C WHEELCHAIR, Substantially Equivalent on 1987-02-10. Applicant: Redman, Inc.. Device class: 2.

Clearance details

Applicant: Redman, Inc.
Product code: Code ITI
Device class: Class 2
Regulation: 21 CFR 890.3860
Advisory panel: Physical Medicine
Date received: 1987-01-28
Decision date: 1987-02-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bloomington, MN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code ITI

view all

K260053 — Power Wheelchair (OS-R-M01I)2026-09-08
K260229 — Electric wheelchair (HC819N, HC830N, HC831N)2026-09-08
K261354 — Electric wheelchair (D03)2026-08-21
K261149 — Electric Wheelchair (DY611A-2, DY612A-1)2026-07-10
K261396 — Electric Wheelchair2026-07-08

More clearances from Redman, Inc.

view all

K935750 — GERONIMO1995-02-03
K935751 — GERONIMO PR1995-02-03
K940851 — RED PACK MANLUAL POWER WHEELCHAIR CONVERSION KIT1995-02-03
K940852 — CHIEF STANDUP WHEELCHAIR1995-02-03
K940919 — CHIEF SR1995-02-03

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, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.