Rib Belt (Universal)

FDA 510(k) K823662 · Warm & Form, Orthopedic Materials

Substantially Equivalent

510(k) numberK823662

Submission

Device name
Rib Belt (Universal)
Applicant
Warm & Form, Orthopedic Materials
Walker, MI, US
Received
December 6, 1982
Decision date
December 30, 1982
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
IPX – Orthosis, Rib Fracture, Soft
Device class
Class I (low risk)
Regulation
21 CFR 890.3490
Specialty
Physical Medicine

Other 510(k)s with product code IPX

510(k)DeviceApplicantDecision
K823158Rib Belt (Universal)IPX · Traditional Warm & Form, Orthopedic Materials11/10/1982SE
K803239Softgood Products and SplintsIPX · Traditional Danek Medical, Inc.01/09/1981SE

More from Danek Medical, Inc.

510(k)DeviceDecision
K830245Head HalterILZ · Traditional 03/09/1983SE
K830244Traction AccessoriesHST · Traditional 03/09/1983SE
K830243Abduction PillowIOZ · Traditional 03/08/1983SE
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
K823661Clavicle SupportIQJ · Traditional 12/30/1982SE

Questions and answers

When was Rib Belt (Universal) cleared by the FDA?

Rib Belt (Universal) (K823662) received a 510(k) decision of Substantially Equivalent on December 30, 1982, 24 days after the submission was received.

What is the product code of K823662?

The FDA product code is IPX – Orthosis, Rib Fracture, Soft, a Class I (low risk) device regulated under 21 CFR 890.3490.