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510(k) K841695

CRAWLER by Maddak, Inc. — Product Code KNL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 10, 1984
Date Received
April 23, 1984
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)
  • K841697 — HYDRO-THERO PAD (May 9, 1984)
  • K841691 — SPLIT SEAT POSITIONING CHAIR (May 9, 1984)
  • K841693 — STANDING FRAME (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)
  • K833090 — SENSORY ROLLER MASSAGER (October 14, 1983)

Other clearances for product code KNL

  • K811489 — SCOOTER BOARD (June 12, 1981)
  • K790528 — THERAPY GYROSCOPE (April 3, 1979)
  • K781198 — BOARD, SCOOTER (July 31, 1978)
  • K780296 — THERAPY SCOOTER (February 24, 1978)