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510(k) K921027

MANUAL CHAIR BASE by Labac Systems, Inc. — Product Code KNN

K921027 is an FDA 510(k) premarket notification submitted by Labac Systems, Inc. for the device "MANUAL CHAIR BASE". The FDA issued a decision of Substantially Equivalent on March 20, 1992. The device falls under product code KNN (Components, Wheelchair), a Class I device regulated under 21 CFR 890.3920. Labac Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 20, 1992
Date Received
March 3, 1992
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 Labac Systems, Inc.

  • K941157 — BASIC RECLINE CHAIR (April 7, 1994)
  • K934418 — BASIC TILT CHAIR ( BTC ) (January 7, 1994)
  • K932639 — MANUAL TILT RECLINE CHAIR (MTC) (July 22, 1993)
  • K923362 — REDUCED SHEAR OWR RECLINE SYSTEM (March 26, 1993)
  • K921028 — MANUAL RECLINING CHAIR (March 24, 1993)
  • K923363 — ADJUSTABLE SLIDING BACK POWER RECLINE SYSTEM (March 24, 1993)
  • K923364 — TILT ADJUSTABLE SLIDING BACK RECLINE SEATING SYST (March 22, 1993)
  • K925272 — PEDIATRIC TILT CHAIR (February 12, 1993)
  • K923366 — TILT SEATING SYSTEM (February 12, 1993)
  • K921136 — MANUAL TILT CHAIR (April 2, 1992)

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)
  • K942309 — DYNASTY U1-31 (GELL/CELL) (November 7, 1994)
  • K942308 — DYNASTY GC 12400 (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)
  • 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