Home / 510(k) Clearances / K830842

510(k) K830842

OB HELP ARM by Lic-Orthion — Product Code ILE

K830842 is an FDA 510(k) premarket notification submitted by Lic-Orthion for the device "OB HELP ARM". The FDA issued a decision of Substantially Equivalent on April 5, 1983. The device falls under product code ILE (Sling, Arm, Overhead Supported), a Class I device regulated under 21 CFR 890.3475. Lic-Orthion has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 5, 1983
Date Received
March 17, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sling, Arm, Overhead Supported
Device Class
Class I
Regulation Number
890.3475
Review Panel
PM
Submission Type

Other clearances by Lic-Orthion

  • K891649 — PATIENT EXAMINATION GLOVES (LATEX) (April 4, 1989)
  • K862022 — LIC-ORTHION MULTI-THERAPY TREATMENT TABLE (June 19, 1986)
  • K854730 — DAISY (ABSORBENT INCONTINENCE SHIELD) (February 6, 1986)
  • K854729 — ADAM (ABSORBENT INCONTINENCE SHIELD) (February 6, 1986)
  • K851471 — TRIBAG, TRIBAND & TRIFIX-REUSEABLE URINE COLLECTOR (June 12, 1985)
  • K851470 — BIBAG, BIBAND & BIFIX - SINGLE USE URINE COLLECTOR (June 12, 1985)
  • K843233 — ANATOM SYSTEM (October 25, 1984)
  • K843234 — CITOMAT AUTOCLAVES (October 25, 1984)
  • K830853 — LAVATORY SEAT HEIGHTENER (June 8, 1983)
  • K830855 — SESAM TREATMENT TABLE (April 5, 1983)

Other clearances for product code ILE

  • K823811 — OVERHEAD ARM SLINGS (January 14, 1983)
  • K823152 — OB HELP ARM (November 5, 1982)

FDA data resources