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510(k) K790558

CERSA-CANE by Maddak, Inc. — Product Code IPS

K790558 is an FDA 510(k) premarket notification submitted by Maddak, Inc. for the device "CERSA-CANE". The FDA issued a decision of Substantially Equivalent on April 3, 1979. The device falls under product code IPS (Cane), a Class I device regulated under 21 CFR 890.3075. 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 19, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cane
Device Class
Class I
Regulation Number
890.3075
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 IPS

  • K832970 — CANE REACHER (September 29, 1983)
  • K832969 — WALKING CANE (September 29, 1983)
  • K821402 — LIGHT WEIGHT ALUMINUM CANES (April 21, 1982)
  • K790561 — OFFSET ALUMINUM CANE (April 3, 1979)
  • K790299 — FOREARM-CANE (February 21, 1979)
  • K780085 — CANE/REACHER (January 30, 1978)
  • K772267 — QUADRAPLEGIC WALKING AID (December 20, 1977)
  • K770529 — UNICET I (April 5, 1977)

FDA data resources