Home / 510(k) Clearances / K920860

510(k) K920860

CONTROLLED PASSIVE MOTION MACHINE by U.S. Mfg. & Management, Inc. — Product Code BXB

K920860 is an FDA 510(k) premarket notification submitted by U.S. Mfg. & Management, Inc. for the device "CONTROLLED PASSIVE MOTION MACHINE". The FDA issued a decision of Substantially Equivalent on April 2, 1992. The device falls under product code BXB (Exerciser, Powered), a Class I device regulated under 21 CFR 890.5380. U.S. Mfg. & Management, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 2, 1992
Date Received
February 25, 1992
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 U.S. Mfg. & Management, Inc.

  • K874436 — FLUID SAMPLING PACK (January 5, 1988)
  • K862335 — MODIFIED I.V. START, RE-START, PEDI AND GERI-KIT (July 24, 1986)
  • K853242 — I.V. START KIT, I.V. RESTART KIT, PEDI-KIT,GERI-KI (August 30, 1985)
  • K842999 — VENI-SHIELD (September 24, 1984)

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)
  • K955105 — BTE CPM-10 (December 29, 1995)
  • K955106 — BTE CPM-20 (December 29, 1995)
  • K951028 — HAMEX TWO (December 11, 1995)
  • K950755 — FLEXMATE K500 (October 5, 1995)
  • K951029 — HAMEX ONE (September 15, 1995)
  • K945733 — AQUAHAB, MODEL 120-72-101 (September 15, 1995)

FDA data resources