510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K946169Substantially Equivalent

Actic 2002

North Atlantic Rehabilitation, Inc., West Bend WI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K946169 is the FDA 510(k) clearance record for ACTIC 2002, a class I device, cleared for North Atlantic Rehabilitation, Inc. on under FDA product code BXB (Exerciser, Powered). FDA records list one 510(k) clearance for North Atlantic Rehabilitation, Inc. As of , FDA records show no recalls naming K946169.

Clearance record

Decision date
Received
(178 days to decision)
Product code
BXB Exerciser, Powered
Regulation
21 CFR 890.5380
Device class
Class I
Review panel
Physical Medicine
Applicant
North Atlantic Rehabilitation, Inc. 2021 Barton Ave. #207, West Bend WI
510(k) summary
Statement
Third party review
No

Clearances, product code BXB

Trailing 12 months

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

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