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510(k) K063521

NISSIN PEDIATRIC SERIES WHEELCHAIR by Nissin Medical, Inc. — Product Code INM

K063521 is an FDA 510(k) premarket notification submitted by Nissin Medical, Inc. for the device "NISSIN PEDIATRIC SERIES WHEELCHAIR". The FDA issued a decision of Substantially Equivalent on February 5, 2007. The device falls under product code INM (Chair, With Casters), a Class I device regulated under 21 CFR 890.3100.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 5, 2007
Date Received
November 22, 2006
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 for product code INM

  • 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)
  • K926025 — CHAIRS (March 22, 1993)
  • K926053 — ELD-ARONDAK CHAIR (March 22, 1993)
  • K926054 — ELD-ARONDAK CHAIR (March 22, 1993)
  • K925247 — STONEHEART ROLLER AID (February 12, 1993)
  • K924848 — KAYE SCOOT-ABOUT, MODEL SB1 (February 12, 1993)
  • K922045 — SHOWER CHAIRS (May 26, 1992)

FDA data resources