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510(k) K933051

ZERO GRAVITY WHEELCHAIR COMPONENTS, MODIFICATION by General Components Intl., Inc. — Product Code KNN

K933051 is an FDA 510(k) premarket notification submitted by General Components Intl., Inc. for the device "ZERO GRAVITY WHEELCHAIR COMPONENTS, MODIFICATION". The FDA issued a decision of Substantially Equivalent on October 12, 1993. The device falls under product code KNN (Components, Wheelchair), a Class I device regulated under 21 CFR 890.3920. General Components Intl., Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 12, 1993
Date Received
May 25, 1993
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 General Components Intl., Inc.

  • K931751 — ZERO GRAVITY WHEELCHAIR (July 22, 1993)

Other clearances for product code KNN

  • K211919 — KISS Dynamic Back Support, KISS Dynamic Solid Drop Seat (March 4, 2022)
  • K942311 — DYNASTY U1-33 AGM (November 7, 1994)
  • K942308 — DYNASTY GC 12400 (GELL/CELL) (November 7, 1994)
  • K942309 — DYNASTY U1-31 (GELL/CELL) (November 7, 1994)
  • K942310 — DYNASTY GC 12550 (GELL/CELL) (November 7, 1994)
  • K942312 — ALDEN LINEAGE WHEELCHAIR CUSHION (May 26, 1994)
  • K942260 — ALDEN WHEELCHAIR CUSHION (May 26, 1994)
  • K925980 — PM (March 24, 1993)
  • K923942 — RHOMBO MEDICAL RHOMBO-FILL (March 24, 1993)
  • K923364 — TILT ADJUSTABLE SLIDING BACK RECLINE SEATING SYST (March 22, 1993)

FDA data resources