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510(k) K862730

DANNIFLEX 400SL by Danninger Medical Technology, Inc. — Product Code BXB

K862730 is an FDA 510(k) premarket notification submitted by Danninger Medical Technology, Inc. for the device "DANNIFLEX 400SL". The FDA issued a decision of Substantially Equivalent on July 24, 1986. The device falls under product code BXB (Exerciser, Powered), a Class I device regulated under 21 CFR 890.5380. Danninger Medical Technology, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 24, 1986
Date Received
July 18, 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 Danninger Medical Technology, Inc.

  • K931128 — BASIC SHOULDER CPM (May 6, 1994)
  • K933394 — DANNIFLEX CPM 600 (March 11, 1994)
  • K913026 — TTU-100THERMAL THERAPY UNIT (December 13, 1991)
  • K875223 — DANNINGER ORTHOPAEDIC AWL (February 17, 1988)
  • K844033 — MOBILIMB HAND UNIT (November 27, 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)
  • 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