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510(k) K935520

UPPER BODY CYCLES (110 VOLT)/(220 VOLT) by Biodex Medical Systems, Inc. — Product Code BXB

K935520 is an FDA 510(k) premarket notification submitted by Biodex Medical Systems, Inc. for the device "UPPER BODY CYCLES (110 VOLT)/(220 VOLT)". The FDA issued a decision of Substantially Equivalent on September 16, 1994. The device falls under product code BXB (Exerciser, Powered), a Class I device regulated under 21 CFR 890.5380. Biodex Medical Systems, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 16, 1994
Date Received
November 18, 1993
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 Biodex Medical Systems, Inc.

  • K090296 — ATOMLAB 400 AND ATOMLAB 500 DOSE CALIBRATORS, MODELS 086-330, -331, -332, -335 A (February 19, 2009)
  • K063666 — SHARPS CONTAINER, MODEL 039-413 (January 25, 2007)
  • K951770 — BIODEX SYSTEM 3 MODEL S3S-AP AND MODEL S3D-3AP (November 16, 1995)
  • K950981 — ULTRA-PRO ULTRASOUND SCANNING TABLE MODEL #056-650 (April 3, 1995)
  • K942694 — STABILITY SYSTEM (110V) MODEL 945-300; STABILITY SYSTEM (220V) MODEL #945-302 (March 10, 1995)
  • K940301 — COMPEX 2 (December 28, 1994)
  • K935216 — SEMI-RECUMBENT CYCLES (September 16, 1994)
  • K935061 — LOWER BODY CYCLES (September 16, 1994)

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