Manual Chair Base

FDA 510(k) K921027 · Labac Systems, Inc.

Substantially Equivalent

510(k) numberK921027

Submission

Device name
Manual Chair Base
Applicant
Labac Systems, Inc.
Highlands Ranch, CO, US
Received
March 3, 1992
Decision date
March 20, 1992
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
KNN – Components, Wheelchair
Device class
Class I (low risk)
Regulation
21 CFR 890.3920
Specialty
Physical Medicine

Other 510(k)s with product code KNN

510(k)DeviceApplicantDecision
K211919KISS Dynamic Back Support, KISS Dynamic Solid Drop SeatKNN · Traditional Kinetic Innovative Seating System, LLC03/04/2022SE
K942311Dynasty U1-33 AgmKNN · Traditional Foley & Lardner11/07/1994SE
K942310Dynasty GC 12550 (Gell/Cell)KNN · Traditional Foley & Lardner11/07/1994SE
K942309Dynasty U1-31 (Gell/Cell)KNN · Traditional Foley & Lardner11/07/1994SE
K942308Dynasty GC 12400 (Gell/Cell)KNN · Traditional Foley & Lardner11/07/1994SE
K942312Alden Lineage Wheelchair CushionKNN · Traditional Lewis W. Ward05/26/1994SE
K942260Alden Wheelchair CushionKNN · Traditional Ward and Assoc.05/26/1994SE
K933051Zero Gravity Wheelchair Components, ModificationKNN · Traditional General Components Intl., Inc.10/12/1993SE
K925980PMKNN · Traditional Pathfinder Intl. Corp.03/24/1993SE
K923942Rhombo Medical Rhombo-FillKNN · Traditional International Medical Products, Inc.03/24/1993SE

More from International Medical Products, Inc.

510(k)DeviceDecision
K941157Basic Recline ChairIOR · Traditional 04/07/1994SE
K934418Basic Tilt Chair ( BTC )IOR · Traditional 01/07/1994SE
K932639Manual Tilt Recline Chair (MTC)IOR · Traditional 07/22/1993SE
K923362Reduced Shear Owr Recline SystemITI · Traditional 03/26/1993SE
K923363Adjustable Sliding Back Power Recline SystemITI · Traditional 03/24/1993SE
K921028Manual Reclining ChairIOR · Traditional 03/24/1993SE
K923364Tilt Adjustable Sliding Back Recline Seating SystKNN · Traditional 03/22/1993SE
K925272Pediatric Tilt ChairIOR · Traditional 02/12/1993SE
K923366Tilt Seating SystemKNN · Traditional 02/12/1993SE
K921136Manual Tilt ChairIOR · Traditional 04/02/1992SE

Questions and answers

When was Manual Chair Base cleared by the FDA?

Manual Chair Base (K921027) received a 510(k) decision of Substantially Equivalent on March 20, 1992, 17 days after the submission was received.

What is the product code of K921027?

The FDA product code is KNN – Components, Wheelchair, a Class I (low risk) device regulated under 21 CFR 890.3920.