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510(k) K900839

THE CAROLINA ROCKER by Artec Environmental Monitoring Division — Product Code KNN

K900839 is an FDA 510(k) premarket notification submitted by Artec Environmental Monitoring Division for the device "THE CAROLINA ROCKER". The FDA issued a decision of Substantially Equivalent on April 18, 1990. The device falls under product code KNN (Components, Wheelchair), a Class I device regulated under 21 CFR 890.3920. Artec Environmental Monitoring Division has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 18, 1990
Date Received
February 22, 1990
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 Artec Environmental Monitoring Division

  • K896886 — ARTEC RESPOND PULMONARY RESUSCITATOR (February 6, 1990)
  • K873043 — MOUTH TO FACE RESUSCITATOR (September 28, 1987)
  • K863910 — RAINCOAT (October 20, 1986)
  • K854573 — ANESTHESIA SHUTOFF VALVE POSITIVE CLOSURE (January 3, 1986)
  • K832512 — AIRWAY MASKS (January 17, 1984)
  • K830056 — ARTEC TWIST VALVE (March 9, 1983)

Other clearances for product code KNN

  • K211919 — KISS Dynamic Back Support, KISS Dynamic Solid Drop Seat (March 4, 2022)
  • K942309 — DYNASTY U1-31 (GELL/CELL) (November 7, 1994)
  • K942310 — DYNASTY GC 12550 (GELL/CELL) (November 7, 1994)
  • K942311 — DYNASTY U1-33 AGM (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