510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K172601Substantially Equivalent

Next Generation iBOT

Deka Research & Development Corp., Manchester NH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K172601 is the FDA 510(k) clearance record for Next Generation iBOT, a class II device, cleared for Deka Research & Development Corp. on under FDA product code IMK (Wheelchair, Stair Climbing). FDA's definition for product code IMK reads: "A device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. The device is intended to climb stairs. FDA interprets “mobility to persons restricted to a sitting position” to...". FDA records list 28 510(k) clearances for Deka Research & Development Corp., from to . As of , FDA records show no recalls naming K172601.

Clearance record

Decision date
Received
(184 days to decision)
Product code
IMK Wheelchair, Stair Climbing
Regulation
21 CFR 890.3890
Device class
Class II
Review panel
Physical Medicine
Applicant
Deka Research & Development Corp. 340 Commercial St., Manchester NH
510(k) summary
Summary PDF
Third party review
No

Clearances, product code IMK

Trailing 12 months

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

FDA records show no clearances under product code IMK in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code IMK, 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