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510(k) K790587

CANVAS WEDGE by Maddak, Inc. — Product Code IOD

K790587 is an FDA 510(k) premarket notification submitted by Maddak, Inc. for the device "CANVAS WEDGE". The FDA issued a decision of Substantially Equivalent on April 3, 1979. The device falls under product code IOD (Components, Exercise), a Class I device regulated under 21 CFR 890.5350. Maddak, Inc. has at least 10 other 510(k) clearances on record.

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)
  • K841695 — CRAWLER (May 10, 1984)
  • K841698 — HEAT PACK (May 10, 1984)
  • K841693 — STANDING FRAME (May 9, 1984)
  • K841697 — HYDRO-THERO PAD (May 9, 1984)
  • K841691 — SPLIT SEAT POSITIONING CHAIR (May 9, 1984)
  • K841692 — PRONE STANDER (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)

FDA data resources