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510(k) K820858

ESCORT by Amigo Sales, Inc. — Product Code INM

K820858 is an FDA 510(k) premarket notification submitted by Amigo Sales, Inc. for the device "ESCORT". The FDA issued a decision of Substantially Equivalent on April 8, 1982. The device falls under product code INM (Chair, With Casters), a Class I device regulated under 21 CFR 890.3100. Amigo Sales, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 8, 1982
Date Received
March 29, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Chair, With Casters
Device Class
Class I
Regulation Number
890.3100
Review Panel
PM
Submission Type

Other clearances by Amigo Sales, Inc.

  • K871391 — AMIGO-A288310 (SCOOTER, COMMUTER CART, 3-WHEELED) (May 6, 1987)
  • K853918 — THE SPORTSTER (ELECTRIFIED WHEELCHAIR) (January 13, 1986)
  • K852557 — ALL TERRAIN AMIGO (August 22, 1985)
  • K830345 — SCOOTER, VEHICLE MOTORIZED (March 10, 1983)
  • K823117 — HITCH HIKER (November 16, 1982)
  • K800209 — BOOTS - OUTDOOR CARRIER FOR THE AMIGO (February 22, 1980)

Other clearances for product code INM

  • K063521 — NISSIN PEDIATRIC SERIES WHEELCHAIR (February 5, 2007)
  • K941738 — STRYKER 5050 STRECHAIR (May 6, 1994)
  • K941569 — CAREMOR CLINER (April 26, 1994)
  • K933000 — RECLINING GERI CHAIRS W/CASTERS & LAP TRAY (September 30, 1993)
  • K926028 — BENCHES (March 24, 1993)
  • K926053 — ELD-ARONDAK CHAIR (March 22, 1993)
  • K926054 — ELD-ARONDAK CHAIR (March 22, 1993)
  • K926025 — CHAIRS (March 22, 1993)
  • K924848 — KAYE SCOOT-ABOUT, MODEL SB1 (February 12, 1993)
  • K925247 — STONEHEART ROLLER AID (February 12, 1993)

FDA data resources