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510(k) K863639

ARTICULAR MOTION DEVICE (AMD4000) by Med Surg Designs, Inc. — Product Code BXB

K863639 is an FDA 510(k) premarket notification submitted by Med Surg Designs, Inc. for the device "ARTICULAR MOTION DEVICE (AMD4000)". The FDA issued a decision of Substantially Equivalent on September 29, 1986. The device falls under product code BXB (Exerciser, Powered), a Class I device regulated under 21 CFR 890.5380. Med Surg Designs, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 1986
Date Received
September 17, 1986
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 Med Surg Designs, Inc.

  • K850122 — SONI-LOK SCOPE STABILIZER (February 21, 1985)

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)
  • K951029 — HAMEX ONE (September 15, 1995)
  • K945733 — AQUAHAB, MODEL 120-72-101 (September 15, 1995)

FDA data resources