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510(k) K812654

VELCRO FINGER/TOE SPLINT by Maddak, Inc. — Product Code ILH

K812654 is an FDA 510(k) premarket notification submitted by Maddak, Inc. for the device "VELCRO FINGER/TOE SPLINT". The FDA issued a decision of Substantially Equivalent on September 25, 1981. The device falls under product code ILH (Splint, Hand, And Components), a Class I device regulated under 21 CFR 890.3475. Maddak, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 25, 1981
Date Received
September 17, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Splint, Hand, And Components
Device Class
Class I
Regulation Number
890.3475
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)
  • K841693 — STANDING FRAME (May 9, 1984)
  • K841692 — PRONE STANDER (May 9, 1984)
  • K841691 — SPLIT SEAT POSITIONING CHAIR (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 ILH

  • K832144 — SPLINT WOOD (August 1, 1983)
  • K831548 — SPLINTS (June 27, 1983)
  • K823644 — FINGER FLEXION SPLINT (January 21, 1983)
  • K823647 — FINGER EXTENSION SPLINT (January 21, 1983)
  • K823666 — UNIVERSAL WRIST SPLINT & FOREARM SPLINT (December 30, 1982)
  • K823601 — WRIST SUPPORT (December 22, 1982)
  • K823393 — STAX FINGER SPLINTS (December 3, 1982)
  • K823165 — WRIST SPLING & FOREARM SPLINT (November 16, 1982)
  • K822651 — TOTAL FINGER FLEXION SPLINT (September 17, 1982)
  • K821635 — SOFT ULNAR DEVIATION SPLINTS (June 11, 1982)

FDA data resources