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510(k) K861751

THE FITZ KIT, MOLDED/CUSTOM WHEELCHAIR SEATING SYS by Special Health Systems, Ltd. — Product Code KNN

K861751 is an FDA 510(k) premarket notification submitted by Special Health Systems, Ltd. for the device "THE FITZ KIT, MOLDED/CUSTOM WHEELCHAIR SEATING SYS". The FDA issued a decision of Substantially Equivalent on May 23, 1986. The device falls under product code KNN (Components, Wheelchair), a Class I device regulated under 21 CFR 890.3920. Special Health Systems, Ltd. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 23, 1986
Date Received
May 6, 1986
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 Special Health Systems, Ltd.

  • K861755 — SHS CUSHION/WHEELCHAIR (May 23, 1986)
  • K861754 — KINESETHETIC SEATING SYSTEM/WHEELCHAIR (May 23, 1986)

Other clearances for product code KNN

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

FDA data resources