Abduction Pillow

FDA 510(k) K830243 · Warm & Form, Orthopedic Materials

Substantially Equivalent

510(k) numberK830243

Submission

Device name
Abduction Pillow
Applicant
Warm & Form, Orthopedic Materials
Mchenry, IL, US
Received
January 25, 1983
Decision date
March 8, 1983
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
IOZ – Splint, Abduction, Congenital Hip Dislocation
Device class
Class I (low risk)
Regulation
21 CFR 890.3665
Specialty
Physical Medicine

Other 510(k)s with product code IOZ

510(k)DeviceApplicantDecision
K823820Abduction PillowIOZ · Traditional Danek Medical, Inc.01/14/1983SE
K810557Hip Abduction SplintIOZ · Traditional Orthomedics03/13/1981SE
K780375Pavlik HarnessIOZ · Traditional Biomet, Inc.03/15/1978SE

More from Biomet, Inc.

510(k)DeviceDecision
K830245Head HalterILZ · Traditional 03/09/1983SE
K830244Traction AccessoriesHST · Traditional 03/09/1983SE
K830246Cast Shoe, Cast BootJQB · Traditional 02/18/1983SE
K823667Cervical CollarIQK · Traditional 12/30/1982SE
K823666Universal Wrist Splint & Forearm SplintILH · Traditional 12/30/1982SE
K823665Rotation BootKNP · Traditional 12/30/1982SE
K823664Universal Sling, Sling & SwatheILI · Traditional 12/30/1982SE
K823663Abdominal BinderKTD · Traditional 12/30/1982SE
K823662Rib Belt (Universal)IPX · Traditional 12/30/1982SE
K823661Clavicle SupportIQJ · Traditional 12/30/1982SE

Questions and answers

When was Abduction Pillow cleared by the FDA?

Abduction Pillow (K830243) received a 510(k) decision of Substantially Equivalent on March 8, 1983, 42 days after the submission was received.

What is the product code of K830243?

The FDA product code is IOZ – Splint, Abduction, Congenital Hip Dislocation, a Class I (low risk) device regulated under 21 CFR 890.3665.