Cleared Traditional

K830316 - UNIFLEX

K830316 is an FDA 510(k) clearance for UNIFLEX, manufactured by Buckman Consultants. The device is a Class 1 Physical Medicine device with product code BXB cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K830316 · Buckman Consultants · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1983
Decision
52d
Days
Class 1
Risk

K830316 is an FDA 510(k) clearance for the UNIFLEX. Classified as Exerciser, Powered (product code BXB), Class I - General Controls.

Submitted by Buckman Consultants (Mchenry, US). The FDA issued a Cleared decision on March 24, 1983 after a review of 52 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K830316

510(k) Number K830316 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 1983
Decision Date March 24, 1983
Days to Decision 52 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
64d faster than avg
Panel avg: 116d · This submission: 52d
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 158
Devices cleared under the same product code (BXB) and FDA review panel - the closest regulatory comparables to K830316.
FLEXXR* CPM SYSTEM
K834203 · Qarex Laboratories, Inc. · Jan 1984
STRYKER LEG EXERCISER
K831910 · Stryker Corp. · Jul 1983
PATIENT GUIDED ELBOW & SHOULDER EXERC
K830793 · Richard'S Medical Equip., Inc. · Jun 1983
SUTTER CPM 2000
K830649 · Sutter Biomedical, Inc. · Mar 1983
POWER FLEX
K830369 · Biodynamic Technologies of Florida · Mar 1983
CONTINUOUS ANATOMICAL PASSIVE EXERCISER
K830122 · Zimmer, Inc. · Feb 1983
K830316 · UNIFLEX
Download PDF Buckman Consultants