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510(k) K903532

UNNA-SLEEVE(TM) by Aci Medical, Inc. — Product Code LLK

K903532 is an FDA 510(k) premarket notification submitted by Aci Medical, Inc. for the device "UNNA-SLEEVE(TM)". The FDA issued a decision of Substantially Equivalent on November 2, 1990. The device falls under product code LLK (Legging, Compression, Non-Inflatable), a Class II device regulated under 21 CFR 880.5780. Aci Medical, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 2, 1990
Date Received
August 6, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Legging, Compression, Non-Inflatable
Device Class
Class II
Regulation Number
880.5780
Review Panel
HO
Submission Type

Other clearances by Aci Medical, Inc.

  • K131146 — ARTASSIST AND VENASSIST (February 10, 2014)
  • K942530 — ART-ASSIST MODEL AA-1000 (February 28, 1996)
  • K903894 — VENAPULSE MODELS VP-25 AND VP-50 (April 3, 1991)
  • K881291 — AIR PLETHYSMOGRAPH MODEL APG-1000 (October 14, 1988)
  • K861645 — MICRO-TRACHEOSTOMY CARE KIT (May 9, 1986)
  • K844309 — IV RATEMETER (January 22, 1985)

Other clearances for product code LLK

  • K873368 — TECNOL COMPRESSION KNEE DRESSING (December 11, 1987)
  • K871889 — COMPRESSION LEGGING DEVICE (August 4, 1987)
  • K834460 — MODEL 1888 ALPHA COS/RESPIRATION CAR (February 13, 1984)

FDA data resources