Ob Help Arm

FDA 510(k) K830842 · Lic-Orthion

Substantially Equivalent

510(k) numberK830842

Submission

Device name
Ob Help Arm
Applicant
Lic-Orthion
Mchenry, IL, US
Received
March 17, 1983
Decision date
April 5, 1983
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
ILE – Sling, Arm, Overhead Supported
Device class
Class I (low risk)
Regulation
21 CFR 890.3475
Specialty
Physical Medicine

Other 510(k)s with product code ILE

510(k)DeviceApplicantDecision
K823811Overhead Arm SlingsILE · Traditional Danek Medical, Inc.01/14/1983SE
K823152Ob Help ArmILE · Traditional Orthion Corp.11/05/1982SE

More from Orthion Corp.

510(k)DeviceDecision
K891649Patient Examination Gloves (Latex)LYY · Traditional 04/04/1989SE
K862022Lic-Orthion Multi-Therapy Treatment TableJFB · Traditional 06/19/1986SE
K854730Daisy (Absorbent Incontinence Shield)EYQ · Traditional 02/06/1986SE
K854729Adam (Absorbent Incontinence Shield)EYQ · Traditional 02/06/1986SE
K851471Tribag, Triband & Trifix-Reuseable Urine CollectorKNX · Traditional 06/12/1985SE
K851470Bibag, Biband & Bifix - Single Use Urine CollectorKNX · Traditional 06/12/1985SE
K843234Citomat AutoclavesECG · Traditional 10/25/1984SE
K843233Anatom SystemKLC · Traditional 10/25/1984SE
K830853Lavatory Seat HeightenerILS · Traditional 06/08/1983SE
K830855Sesam Treatment TableINQ · Traditional 04/05/1983SE

Questions and answers

When was Ob Help Arm cleared by the FDA?

Ob Help Arm (K830842) received a 510(k) decision of Substantially Equivalent on April 5, 1983, 19 days after the submission was received.

What is the product code of K830842?

The FDA product code is ILE – Sling, Arm, Overhead Supported, a Class I (low risk) device regulated under 21 CFR 890.3475.