Cleared Traditional

K830793 - PATIENT GUIDED ELBOW & SHOULDER EXERC

K830793 is an FDA 510(k) clearance for PATIENT GUIDED ELBOW & SHOULDER EXERC, manufactured by Richard'S Medical Equip., Inc.. The device is a Class 1 Physical Medicine device with product code BXB cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K830793 · Richard'S Medical Equip., Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1983
Decision
94d
Days
Class 1
Risk

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

Submitted by Richard'S Medical Equip., Inc. (Mchenry, US). The FDA issued a Cleared decision on June 16, 1983 after a review of 94 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5380 - the FDA physical medicine device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Richard'S Medical Equip., Inc. devices

FDA 510(k) Submission Details - K830793

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 -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 115d · This submission: 94d
Pathway characteristics
Predicate-based equivalence.

BXB Device Classification - Class 1, General Controls

Product Code BXB Exerciser, Powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.5380
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - BXB Exerciser, Powered

All 33
Devices cleared under the same product code (BXB) and FDA review panel - the closest regulatory comparables to K830793.
PATIENT GUIDED KNEE EXERCISER
K843493 · Richards Medical Co., Inc. · Sep 1984
CONTINUOUS PASSIVE MOTION
K841674 · Chattanooga Group, Inc. · May 1984
STRYKER LEG EXERCISER
K831910 · Stryker Corp. · Jul 1983
CONTINUOUS ANATOMICAL PASSIVE EXERCISER
K830122 · Zimmer, Inc. · Feb 1983
MOBILIMB-CPM UPPER/LOWER LIMB DEVICE
K823495 · Synthes (Usa) · Jan 1983
AUTORANGE MODEL 205
K822031 · Tri W-G, Inc. · Jul 1982