Home / 510(k) Clearances / K951028

510(k) K951028

HAMEX TWO by Northern Orthopaedic Products, Inc. — Product Code BXB

K951028 is an FDA 510(k) premarket notification submitted by Northern Orthopaedic Products, Inc. for the device "HAMEX TWO". The FDA issued a decision of Substantially Equivalent on December 11, 1995. The device falls under product code BXB (Exerciser, Powered), a Class I device regulated under 21 CFR 890.5380. Northern Orthopaedic Products, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 11, 1995
Date Received
March 7, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Exerciser, Powered
Device Class
Class I
Regulation Number
890.5380
Review Panel
PM
Submission Type

Other clearances by Northern Orthopaedic Products, Inc.

  • K951029 — HAMEX ONE (September 15, 1995)

Other clearances for product code BXB

  • K072887 — G-TRAINER MEDICAL (January 25, 2008)
  • K003272 — FLO-BOOT (April 4, 2001)
  • K952975 — ANKLE CALF EXERCISER PHLEBOPUMP (September 25, 1996)
  • K953456 — E-Z FLEX (January 26, 1996)
  • K955106 — BTE CPM-20 (December 29, 1995)
  • K955105 — BTE CPM-10 (December 29, 1995)
  • K950755 — FLEXMATE K500 (October 5, 1995)
  • K951029 — HAMEX ONE (September 15, 1995)
  • K945733 — AQUAHAB, MODEL 120-72-101 (September 15, 1995)
  • K950682 — W2 WRIST CPM UNIT (September 13, 1995)

FDA data resources