Home / 510(k) Clearances / K822651

510(k) K822651

TOTAL FINGER FLEXION SPLINT by Alimed, Inc. — Product Code ILH

K822651 is an FDA 510(k) premarket notification submitted by Alimed, Inc. for the device "TOTAL FINGER FLEXION SPLINT". The FDA issued a decision of Substantially Equivalent on September 17, 1982. The device falls under product code ILH (Splint, Hand, And Components), a Class I device regulated under 21 CFR 890.3475. Alimed, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 17, 1982
Date Received
September 2, 1982
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 Alimed, Inc.

  • K963527 — UNIVERSAL ECONO-STRAP, QUALCRAFT UNIVERSAL STRAPS (October 31, 1996)
  • K963528 — ALIMED POSITIONING 7 SAFETY STRAPS (THREE TYPES), UNIVERSAL CR/MRI WIDE BODY STR (October 29, 1996)
  • K963526 — STRAP WEDGE (October 28, 1996)
  • K920487 — MINI VIBRATOR (February 18, 1992)
  • K840156 — PROTECTA COAT SPONGES (March 23, 1984)
  • K822650 — SUPER DONUT (September 30, 1982)
  • K820516 — ARTERIAL CANALIZATION DEVICE (April 15, 1982)
  • K820517 — CONSTRUCTA FOAM (March 10, 1982)
  • K801743 — PLASTAZOTE SHOE (August 7, 1980)
  • K791189 — ECHO CARDIOGRAM PAD (July 17, 1979)

Other clearances for product code ILH

  • K832144 — SPLINT WOOD (August 1, 1983)
  • K831548 — SPLINTS (June 27, 1983)
  • K823647 — FINGER EXTENSION SPLINT (January 21, 1983)
  • K823644 — FINGER FLEXION 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)
  • K821635 — SOFT ULNAR DEVIATION SPLINTS (June 11, 1982)
  • K821637 — WIRE-FOAM MP FLEXION SPRING (June 11, 1982)

FDA data resources