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510(k) K913544

DUKKI by Pin Dot Products, Inc. — Product Code INM

K913544 is an FDA 510(k) premarket notification submitted by Pin Dot Products, Inc. for the device "DUKKI". The FDA issued a decision of Substantially Equivalent on August 29, 1991. The device falls under product code INM (Chair, With Casters), a Class I device regulated under 21 CFR 890.3100. Pin Dot Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 29, 1991
Date Received
August 9, 1991
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 Pin Dot Products, Inc.

  • K925258 — DYNAMIC PRESSURE MONITOR 2000M AND 2000C (March 9, 1993)
  • K913510 — MECHANICAL SHAPE SENSOR (September 23, 1991)
  • K913546 — IMPALA CASTERS (September 5, 1991)
  • K913509 — IMPALA WHEELS (September 5, 1991)
  • K913545 — PIN DOT FLIP-DOWN ABDUCTOR (September 5, 1991)
  • K913511 — IMPALA AXLES (September 5, 1991)
  • K913507 — ARMREST (September 5, 1991)
  • K913549 — PIN DOT MOUNTING BRACKETS (September 5, 1991)
  • K913553 — PIN DOT GROWTH/DIAL LINKS (September 5, 1991)
  • K913550 — PIN DOT TRUNION MOUNTS (September 5, 1991)

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

FDA data resources