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510(k) K921369

BIOMEDICAL HORIZONS MODEL 1001 by Biomedical Horizons, Inc. — Product Code KNN

K921369 is an FDA 510(k) premarket notification submitted by Biomedical Horizons, Inc. for the device "BIOMEDICAL HORIZONS MODEL 1001". The FDA issued a decision of Substantially Equivalent on May 11, 1992. The device falls under product code KNN (Components, Wheelchair), a Class I device regulated under 21 CFR 890.3920. Biomedical Horizons, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 11, 1992
Date Received
March 20, 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 Biomedical Horizons, Inc.

  • K971892 — BIOMEDICAL HORIZONS INC. COMPRESSION PUMP, MODEL 651 (August 5, 1998)

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)
  • K942310 — DYNASTY GC 12550 (GELL/CELL) (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)
  • K925980 — PM (March 24, 1993)
  • K923942 — RHOMBO MEDICAL RHOMBO-FILL (March 24, 1993)

FDA data resources