Bottoms-Up TM Pelvic Spinal Posture-Aid

FDA 510(k) K854710 · Reloke Co.

Substantially Equivalent for Some Indications

510(k) numberK854710

Submission

Device name
Bottoms-Up TM Pelvic Spinal Posture-Aid
Applicant
Reloke Co.
Los Angeles, CA, US
Received
November 21, 1985
Decision date
April 16, 1986
Decision
Substantially Equivalent for Some Indications (SN)
Type
Traditional 510(k)

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

Questions and answers

When was Bottoms-Up TM Pelvic Spinal Posture-Aid cleared by the FDA?

Bottoms-Up TM Pelvic Spinal Posture-Aid (K854710) received a 510(k) decision of Substantially Equivalent for Some Indications on April 16, 1986, 146 days after the submission was received.

What is the product code of K854710?

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