Cleared Traditional

K830793 - PATIENT GUIDED ELBOW & SHOULDER EXERC (FDA 510(k) Clearance)

K830793 · Richard'S Medical Equip., Inc. · Physical Medicine device

Jun 1983

Decision

94d

Days

Class 1

Risk

K830793 is an FDA 510(k) clearance for the PATIENT GUIDED ELBOW & SHOULDER EXERC. This device is classified as a Exerciser, Powered (Class I - General Controls, product code BXB).

Submitted by Richard'S Medical Equip., Inc. (Mchenry, US). The FDA issued a Cleared decision on June 16, 1983, 94 days after receiving the submission on March 14, 1983.

This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5380.

Submission Details

510(k) Number	K830793 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 14, 1983
Decision Date	June 16, 1983
Days to Decision	94 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	—