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510(k) K781964

COMPRESSION DEVICES, LIMB by Alba-Waldensian, Inc. — Product Code IRP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 12, 1978
Date Received
November 20, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Massager, Powered Inflatable Tube
Device Class
Class II
Regulation Number
890.5650
Review Panel
PM
Submission Type

Other clearances by Alba-Waldensian, Inc.

  • K020592 — ALBAHEALTH C.A.L.M. SLEEVE, MODEL 59001 (April 3, 2002)
  • K961405 — ALBA HEALTH PAS WRAP SYSTEM (December 26, 1996)
  • K852091 — ALBA DRY BURN PAD (June 13, 1985)
  • K792357 — STERILE IMPERVIOUS ORTHOPEDIC STOCKIN (December 18, 1979)
  • K780570 — TUBULAR DRESSING RETAINER (April 19, 1978)
  • K780547 — STERILE ORTHOPEDIC STOCKINETTE (April 10, 1978)
  • K771913 — HEEL/ELBOW PROTECTOR (November 15, 1977)

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  • K250046 — Air Compression Leg Massager (UM605, UM606, UM607, UM608,UM609,UM610, UM611, UM6 (April 25, 2025)