510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K951029Substantially Equivalent

Hamex One

Northern Orthopaedic Products, Inc., Hamden CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K951029 is the FDA 510(k) clearance record for HAMEX ONE, a class I device, cleared for Northern Orthopaedic Products, Inc. on under FDA product code BXB (Exerciser, Powered). FDA records list 2 510(k) clearances for Northern Orthopaedic Products, Inc., from to . As of , FDA records show no recalls naming K951029.

Clearance record

Decision date
Received
(192 days to decision)
Product code
BXB Exerciser, Powered
Regulation
21 CFR 890.5380
Device class
Class I
Review panel
Physical Medicine
Applicant
Northern Orthopaedic Products, Inc. 54 Wakefield St., Hamden CT
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