Splints

FDA 510(k) K831548 · Fred Sammons, Inc.

Substantially Equivalent

510(k) numberK831548

Submission

Device name
Splints
Applicant
Fred Sammons, Inc.
Mchenry, IL, US
Received
May 12, 1983
Decision date
June 27, 1983
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
ILH – Splint, Hand, And Components
Device class
Class I (low risk)
Regulation
21 CFR 890.3475
Specialty
Physical Medicine

Other 510(k)s with product code ILH

510(k)DeviceApplicantDecision
K832144Splint WoodILH · Traditional Vermont Wood Industries, Inc.08/01/1983SE
K823647Finger Extension SplintILH · Traditional Fred Sammons, Inc.01/21/1983SE
K823644Finger Flexion SplintILH · Traditional Fred Sammons, Inc.01/21/1983SE
K823666Universal Wrist Splint & Forearm SplintILH · Traditional Warm & Form, Orthopedic Materials12/30/1982SE
K823601Wrist SupportILH · Traditional Fred Sammons, Inc.12/22/1982SE
K823393Stax Finger SplintsILH · Traditional Orthopedic Systems, Inc.12/03/1982SE
K823165Wrist Spling & Forearm SplintILH · Traditional Warm & Form, Orthopedic Materials11/16/1982SE
K822651Total Finger Flexion SplintILH · Traditional Alimed, Inc.09/17/1982SE
K821637Wire-Foam MP Flexion SpringILH · Traditional Fred Sammons, Inc.06/11/1982SE
K821635Soft Ulnar Deviation SplintsILH · Traditional Fred Sammons, Inc.06/11/1982SE

More from Fred Sammons, Inc.

510(k)DeviceDecision
K880644Ultra-Pan for Orthotic Plastics (7262)IRQ · Traditional 05/06/1988SE
K880647Adult Perceptual Motor Puzzles (5331-01)HOX · Traditional 04/01/1988SE
K831549Arm SlingsILI · Traditional 06/30/1983SE
K831550Finger Boniometer BK7506KQW · Traditional 06/24/1983SE
K831544Deluxe Traction Exercise Glove BK5035IOD · Traditional 06/24/1983SE
K831543Adjust. WEIGHTS-BK5171-05,10,20 BeokION · Traditional 06/24/1983SE
K831542Adjustable Polycentric Elbow HingeIQI · Traditional 06/24/1983SE
K831553Leg Drainage Bag Strap BK6011KNX · Traditional 06/16/1983SE
K831552Sorbothane Visco Inner Sole PadKNP · Traditional 06/08/1983SE
K831547Raised Toilet Seats & Nail ClippersILS · Traditional 06/08/1983SE

Questions and answers

When was Splints cleared by the FDA?

Splints (K831548) received a 510(k) decision of Substantially Equivalent on June 27, 1983, 46 days after the submission was received.

What is the product code of K831548?

The FDA product code is ILH – Splint, Hand, And Components, a Class I (low risk) device regulated under 21 CFR 890.3475.