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510(k) K925336

VALU-PLUS PAD by Valmed, Inc. — Product Code KNN

K925336 is an FDA 510(k) premarket notification submitted by Valmed, Inc. for the device "VALU-PLUS PAD". The FDA issued a decision of Substantially Equivalent on February 12, 1993. The device falls under product code KNN (Components, Wheelchair), a Class I device regulated under 21 CFR 890.3920. Valmed, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 12, 1993
Date Received
October 22, 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 Valmed, Inc.

  • K181393 — Empty Eva Bag, models FVM0134BP, FVM0135BP, FVM0136BP, FVM0137BP, FVM0138BP, FVM (February 15, 2019)
  • K112148 — POWERED MUSCLE STIMULATOR (April 30, 2012)
  • K101412 — EVA TPN BAG (April 13, 2011)
  • K031611 — P4-FITNESS (September 29, 2004)
  • K022175 — P4 PHYSIO (September 9, 2002)
  • K010754 — NURSE'S ASSISTANT O.R. CONTROL SYSTEM (August 15, 2001)
  • K010716 — VAL LUX 600 SURGICAL LIGHT (PLUS AND RS), MODEL ML600/S: SINGLE LIGHT HEAD, ML60 (May 30, 2001)

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)
  • 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