510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K001391Substantially Equivalent

Bonus Mechanical Wheelchair

Bonus Ent. Corp., San Francisco CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K001391 is the FDA 510(k) clearance record for BONUS MECHANICAL WHEELCHAIR, a class I device, cleared for Bonus Ent. Corp. 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 one 510(k) clearance for Bonus Ent. Corp. As of , FDA records show no recalls naming K001391.

Clearance record

Decision date
Received
(83 days to decision)
Product code
IOR Wheelchair, Mechanical
Regulation
21 CFR 890.3850
Device class
Class I
Review panel
Physical Medicine
Applicant
Bonus Ent. Corp. 228 Lake Merced Hill, San Francisco CA
510(k) summary
Summary
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