510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K020094Substantially Equivalent

En 600-658, En 600-666, En 600-664, En 600-690, En 600-651, En 600-663, En 600-665 and En 600-670 Mechanical Wheelchairs

Regulatory Insight, Inc., Littleton CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K020094 is the FDA 510(k) clearance record for EN 600-658, EN 600-666, EN 600-664, EN 600-690, EN 600-651, EN 600-663, EN 600-665 AND EN 600-670 MECHANICAL WHEELCHAIRS, a class I device, cleared for Regulatory Insight, Inc. on under FDA product code IOR (Wheelchair, Mechanical). FDA's definition for product code IOR reads: "A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. FDA interprets “mobility to persons restricted to a sitting position”...". FDA records list 4 510(k) clearances for Regulatory Insight, Inc., from to . As of , FDA records show no recalls naming K020094.

Clearance record

Decision date
Received
(56 days to decision)
Product code
IOR Wheelchair, Mechanical
Regulation
21 CFR 890.3850
Device class
Class I
Review panel
Physical Medicine
Applicant
Regulatory Insight, Inc. 13 Red Fox Ln., Littleton CO
510(k) summary
Statement
Third party review
No

Clearances, product code IOR

Trailing 12 months
21 clearances under product code IOR in the twelve months to October 2026, September 2026 the highest month at 5.
Show the numbers
Monthly 510(k) clearances under FDA product code IOR, trailing twelve months
MonthClearances
November 20252
December 20252
January 20262
February 20260
March 20261
April 20261
May 20262
June 20264
July 20261
August 20261
September 20265
October 20260