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510(k) K893598

HYDRAULIC FOOT OPERATED STOOL by Arthro-Medic, Inc. — Product Code GBB

K893598 is an FDA 510(k) premarket notification submitted by Arthro-Medic, Inc. for the device "HYDRAULIC FOOT OPERATED STOOL". The FDA issued a decision of Substantially Equivalent on October 10, 1989. The device falls under product code GBB (Chair, Surgical, Ac-Powered), a Class I device regulated under 21 CFR 878.4960. Arthro-Medic, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 10, 1989
Date Received
May 9, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Chair, Surgical, Ac-Powered
Device Class
Class I
Regulation Number
878.4960
Review Panel
SU
Submission Type

Other clearances by Arthro-Medic, Inc.

  • K933597 — AQUA+TFILTERHME/THME/AQUA+TFILTERHCH/THCH (November 1, 1993)
  • K893597 — HYDRAULIC IV POLE (October 10, 1989)
  • K891387 — WILLIAMS BELT & BOOT (May 23, 1989)

Other clearances for product code GBB

  • K964102 — TENET TIBIAL FRACTURE SUPPORT (December 5, 1996)
  • K831325 — NUTROMAT (June 2, 1983)
  • K831385 — LITHOTOMY CHAIR #415 (June 2, 1983)
  • K822264 — NAGASHIMA SN OPERATOR'S CHAIR (October 13, 1982)
  • K822251 — EXAMINATION & TREATMENT CHAIRS (August 27, 1982)
  • K822013 — NAGASHIMA SN AUTOMATIC TREATMENT CHAIR (July 28, 1982)
  • K820636 — STORZ #6500 POWER EXAMINATION CHAIR (March 26, 1982)

FDA data resources