510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K923186Substantially Equivalent

Nexus Wheelchair Cushion/formerly Biothotic

ROHO, Inc., Belleville IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K923186 is the FDA 510(k) clearance record for NEXUS WHEELCHAIR CUSHION/FORMERLY BIOTHOTIC, a class I device, cleared for Roho, Inc. on under FDA product code KNN (Components, Wheelchair). FDA records list 2 510(k) clearances for Roho, Inc., from to . As of , FDA records show no recalls naming K923186.

Clearance record

Decision date
Received
(71 days to decision)
Product code
KNN Components, Wheelchair
Regulation
21 CFR 890.3920
Device class
Class I
Review panel
Physical Medicine
Applicant
Roho, Inc. 100 Florida Ave., Belleville IL
510(k) summary
Statement
Third party review
No

Clearances, product code KNN

Trailing 12 months

FDA records hold no clearances under product code KNN in the trailing twelve months.

FDA records show no clearances under product code KNN in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KNN, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260