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510(k) K913511

IMPALA AXLES by Pin Dot Products, Inc. — Product Code KNN

K913511 is an FDA 510(k) premarket notification submitted by Pin Dot Products, Inc. for the device "IMPALA AXLES". The FDA issued a decision of Substantially Equivalent on September 5, 1991. The device falls under product code KNN (Components, Wheelchair), a Class I device regulated under 21 CFR 890.3920. Pin Dot Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 5, 1991
Date Received
August 7, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Components, Wheelchair
Device Class
Class I
Regulation Number
890.3920
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)
  • K913550 — PIN DOT TRUNION MOUNTS (September 5, 1991)
  • K913548 — PIN DOT ALUMINUM PAN (September 5, 1991)
  • K913545 — PIN DOT FLIP-DOWN ABDUCTOR (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)

Other clearances for product code KNN

  • K211919 — KISS Dynamic Back Support, KISS Dynamic Solid Drop Seat (March 4, 2022)
  • K942310 — DYNASTY GC 12550 (GELL/CELL) (November 7, 1994)
  • K942311 — DYNASTY U1-33 AGM (November 7, 1994)
  • K942309 — DYNASTY U1-31 (GELL/CELL) (November 7, 1994)
  • K942308 — DYNASTY GC 12400 (GELL/CELL) (November 7, 1994)
  • K942260 — ALDEN WHEELCHAIR CUSHION (May 26, 1994)
  • K942312 — ALDEN LINEAGE WHEELCHAIR CUSHION (May 26, 1994)
  • K933051 — ZERO GRAVITY WHEELCHAIR COMPONENTS, MODIFICATION (October 12, 1993)
  • K925980 — PM (March 24, 1993)
  • K923942 — RHOMBO MEDICAL RHOMBO-FILL (March 24, 1993)

FDA data resources