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510(k) K925247

STONEHEART ROLLER AID by Stoneheart, Inc. — Product Code INM

K925247 is an FDA 510(k) premarket notification submitted by Stoneheart, Inc. for the device "STONEHEART ROLLER AID". The FDA issued a decision of Substantially Equivalent on February 12, 1993. 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 12, 1993
Date Received
October 16, 1992
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

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

FDA data resources