Cleared Traditional

K921348 - OIC MODEL J4 TMJ CPM

K921348 is an FDA 510(k) clearance for OIC MODEL J4 TMJ CPM, manufactured by Lm Product Design, Inc.. The device is a Class 1 Physical Medicine device with product code BXB cleared through the Traditional 510(k) pathway after a 139-day FDA review.

K921348 · Lm Product Design, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1992
Decision
139d
Days
Class 1
Risk

K921348 is an FDA 510(k) clearance for the OIC MODEL J4 TMJ CPM. Classified as Exerciser, Powered (product code BXB), Class I - General Controls.

Submitted by Lm Product Design, Inc. (Plantation, US). The FDA issued a Cleared decision on August 5, 1992 after a review of 139 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 Lm Product Design, Inc. devices

FDA 510(k) Submission Details - K921348

510(k) Number K921348 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 1992
Decision Date August 05, 1992
Days to Decision 139 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d slower than avg
Panel avg: 115d · This submission: 139d
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 39
Devices cleared under the same product code (BXB) and FDA review panel - the closest regulatory comparables to K921348.
ARTROMOT K2 CPM
K931555 · Ormed Mfg., Inc. · Jan 1994
ARTROMOT MULTI DIRECTIONAL ANKLE CPM
K924484 · Buckman Co., Inc. · Mar 1993
ARTROMOT SB ELBOW ATTACHMENT
K923857 · Buckman Co., Inc. · Feb 1993
DANNINFLEX CPM 800
K923216 · Buckman Co., Inc. · Aug 1992
DANNIFLEX CPM 2000
K923217 · Buckman Co., Inc. · Aug 1992
DANNIFLEX MODEL 500TM CPM
K904735 · Buckman Co., Inc. · Jan 1991