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510(k) K951029

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

K951029 is an FDA 510(k) premarket notification submitted by Northern Orthopaedic Products, Inc. for the device "HAMEX ONE". The FDA issued a decision of Substantially Equivalent on September 15, 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
September 15, 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.

  • K951028 — HAMEX TWO (December 11, 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)
  • K951028 — HAMEX TWO (December 11, 1995)
  • K950755 — FLEXMATE K500 (October 5, 1995)
  • K945733 — AQUAHAB, MODEL 120-72-101 (September 15, 1995)
  • K950682 — W2 WRIST CPM UNIT (September 13, 1995)

FDA data resources