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510(k) K871391

AMIGO-A288310 (SCOOTER, COMMUTER CART, 3-WHEELED) by Amigo Sales, Inc. — Product Code INF

K871391 is an FDA 510(k) premarket notification submitted by Amigo Sales, Inc. for the device "AMIGO-A288310 (SCOOTER, COMMUTER CART, 3-WHEELED)". The FDA issued a decision of Substantially Equivalent on May 6, 1987. The device falls under product code INF (Scale, Platform, Wheelchair), a Class I device regulated under 21 CFR 890.3940. Amigo Sales, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 6, 1987
Date Received
April 7, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Scale, Platform, Wheelchair
Device Class
Class I
Regulation Number
890.3940
Review Panel
PM
Submission Type

Other clearances by Amigo Sales, Inc.

  • 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)
  • K820858 — ESCORT (April 8, 1982)
  • K800209 — BOOTS - OUTDOOR CARRIER FOR THE AMIGO (February 22, 1980)

Other clearances for product code INF

  • K924441 — U.S. MEDICAL PS-6000 WHEELCHAIR SCALE (February 12, 1993)
  • K910055 — ACME MODEL 8500 WHEELCHAIR SCALE (January 14, 1991)
  • K884908 — ULTRAFLOTATION MEDICAL WHEELCHAIR (December 27, 1988)
  • K760327 — WHEEL'N WEIGH (October 20, 1976)

FDA data resources