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510(k) K923186

NEXUS WHEELCHAIR CUSHION/FORMERLY BIOTHOTIC by Roho, Inc. — Product Code KNN

K923186 is an FDA 510(k) premarket notification submitted by Roho, Inc. for the device "NEXUS WHEELCHAIR CUSHION/FORMERLY BIOTHOTIC". The FDA issued a decision of Substantially Equivalent on September 9, 1992. The device falls under product code KNN (Components, Wheelchair), a Class I device regulated under 21 CFR 890.3920. Roho, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 9, 1992
Date Received
June 30, 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 Roho, Inc.

  • K861327 — ROHO HEEL PAD (June 2, 1986)

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)
  • K942308 — DYNASTY GC 12400 (GELL/CELL) (November 7, 1994)
  • K942311 — DYNASTY U1-33 AGM (November 7, 1994)
  • K942310 — DYNASTY GC 12550 (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)
  • K923942 — RHOMBO MEDICAL RHOMBO-FILL (March 24, 1993)
  • K925980 — PM (March 24, 1993)

FDA data resources