Cleared Traditional

K970234 - SEALED LEAD ACID BATTERY PACK

K970234 is the FDA 510(k) clearance for SEALED LEAD ACID BATTERY PACK by Portable Power Systems, Inc.. It is a Class 2 Radiology device (product code IZL) cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K970234 · Portable Power Systems, Inc. · Radiology device
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May 1997
Decision
101d
Days
Class 2
Risk

K970234 is an FDA 510(k) clearance for the SEALED LEAD ACID BATTERY PACK. Classified as System, X-ray, Mobile (product code IZL), Class II - Special Controls.

Submitted by Portable Power Systems, Inc. (Castle Rock, US). The FDA issued a Cleared decision on May 2, 1997 after a review of 101 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1720 - the FDA radiology and imaging software oversight 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 Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Portable Power Systems, Inc. devices

Submission Details

510(k) Number K970234 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 1997
Decision Date May 02, 1997
Days to Decision 101 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
6d faster than avg
Panel avg: 107d · This submission: 101d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IZL System, X-ray, Mobile
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1720
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - IZL System, X-ray, Mobile

All 118
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