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510(k) K790587

CANVAS WEDGE by Maddak, Inc. — Product Code IOD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 3, 1979
Date Received
March 27, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Components, Exercise
Device Class
Class I
Regulation Number
890.5350
Review Panel
PM
Submission Type

Other clearances by Maddak, Inc.

  • K841700 — WALK & ROLL (May 11, 1984)
  • K841698 — HEAT PACK (May 10, 1984)
  • K841695 — CRAWLER (May 10, 1984)
  • K841697 — HYDRO-THERO PAD (May 9, 1984)
  • K841693 — STANDING FRAME (May 9, 1984)
  • K841692 — PRONE STANDER (May 9, 1984)
  • K841691 — SPLIT SEAT POSITIONING CHAIR (May 9, 1984)
  • K834311 — NIGHT TRAINER (March 30, 1984)
  • K833870 — KNEE WALKER (November 29, 1983)
  • K833177 — GLOSSECTOMY FEEDING SPOONS (October 31, 1983)

Other clearances for product code IOD

  • K831544 — DELUXE TRACTION EXERCISE GLOVE BK5035 (June 24, 1983)
  • K823648 — SURGICAL TUBING (January 21, 1983)
  • K823822 — ANKLE WEIGHTS (January 14, 1983)
  • K823600 — SOLID WOOD CONE (December 22, 1982)
  • K813632 — COLOR CODED WEIGHT CUFFS (January 19, 1982)
  • K812319 — THERAPY BENCH (August 31, 1981)
  • K772414 — SANDBAGS, VARIOUS WEIGHTS (February 1, 1978)
  • K771030 — FLEXION MITTENS (June 27, 1977)
  • K761118 — HAND SCREW CLAMP (December 2, 1976)
  • K761119 — SHEET METAL CLAMP (December 2, 1976)