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510(k) K833870

KNEE WALKER by Maddak, Inc. — Product Code ION

K833870 is an FDA 510(k) premarket notification submitted by Maddak, Inc. for the device "KNEE WALKER". The FDA issued a decision of Substantially Equivalent on Nov 29, 1983. The device falls under product code ION (Exerciser, Non-Measuring), a Class I device regulated under 21 CFR 890.5370. Maddak, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Nov 29, 1983
Date Received
Nov 8, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Exerciser, Non-Measuring
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)
  • K841697 — HYDRO-THERO PAD (May 9, 1984)
  • K841692 — PRONE STANDER (May 9, 1984)
  • K841691 — SPLIT SEAT POSITIONING CHAIR (May 9, 1984)
  • K841693 — STANDING FRAME (May 9, 1984)
  • K834311 — NIGHT TRAINER (Mar 30, 1984)
  • K833177 — GLOSSECTOMY FEEDING SPOONS (Oct 31, 1983)
  • K833090 — SENSORY ROLLER MASSAGER (Oct 14, 1983)

Other clearances for product code ION

  • K120783 — ABLE-X (Jun 20, 2012)
  • K885343 — STANDEX (May 1, 1989)
  • K851065 — GRAVITY KING (DEEMED SE 87/09/18) (Jun 13, 1985)
  • K840551 — MOBILIZER (Mar 23, 1984)
  • K833249 — FITNESS (Nov 7, 1983)
  • K832968 — PEDAL EXERCISER (Sep 29, 1983)
  • K831543 — ADJUST. WEIGHTS-BK5171-05,10,20 BEOK (Jun 24, 1983)
  • K831538 — DELUXE ADJUST-ANGLE BOARD-BK4066 (Jun 8, 1983)
  • K831033 — GIREX (Apr 27, 1983)
  • K830400 — MADDATRAINER HAND EXERCISER (Mar 9, 1983)

FDA data resources