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510(k) K822650

SUPER DONUT by Alimed, Inc. — Product Code KME

K822650 is an FDA 510(k) premarket notification submitted by Alimed, Inc. for the device "SUPER DONUT". The FDA issued a decision of Substantially Equivalent on September 30, 1982. The device falls under product code KME (Bedding, Disposable, Medical), a Class I device regulated under 21 CFR 880.6060. Alimed, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 30, 1982
Date Received
September 2, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bedding, Disposable, Medical
Device Class
Class I
Regulation Number
880.6060
Review Panel
HO
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)
  • K822651 — TOTAL FINGER FLEXION SPLINT (September 17, 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 KME

  • K042145 — READY-HEAT BLANKET (September 17, 2004)
  • K944953 — OREX MEDICAL BEDDING (December 2, 1994)
  • K933636 — DISPOSE-A-SHEET (January 26, 1994)
  • K932539 — DOCTOR DOWN --RESCUE WRAP (November 2, 1993)
  • K922143 — AMERICAN BURN SHEET (August 10, 1992)
  • K915303 — FOIL BABY BUNTING (February 20, 1992)
  • K912257 — CHEM-SLEEVE B (December 31, 1991)
  • K911953 — MEDI GUARD SHEETS/UNDERLAYS (May 28, 1991)
  • K911948 — MEDI GUARD PILLOWCASE (May 28, 1991)
  • K911952 — MEDI GUARD UNDERPAD (May 28, 1991)

FDA data resources