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510(k) K790528

THERAPY GYROSCOPE by Maddak, Inc. — Product Code KNL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 3, 1979
Date Received
March 15, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Board, Scooter, Prone
Device Class
Class I
Regulation Number
890.5370
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)
  • K841691 — SPLIT SEAT POSITIONING CHAIR (May 9, 1984)
  • K841693 — STANDING FRAME (May 9, 1984)
  • K841697 — HYDRO-THERO PAD (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 KNL

  • K841695 — CRAWLER (May 10, 1984)
  • K811489 — SCOOTER BOARD (June 12, 1981)
  • K781198 — BOARD, SCOOTER (July 31, 1978)
  • K780296 — THERAPY SCOOTER (February 24, 1978)