Cleared Traditional

K951727 - Z-WATCH SYSTEM

K951727 is an FDA 510(k) clearance for Z-WATCH SYSTEM, manufactured by Prizm Medical, Inc.. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Traditional 510(k) pathway after a 222-day FDA review.

K951727 · Prizm Medical, Inc. · Physical Medicine device
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Nov 1995
Decision
222d
Days
Class 2
Risk

K951727 is an FDA 510(k) clearance for the Z-WATCH SYSTEM. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Prizm Medical, Inc. (Norcross, US). The FDA issued a Cleared decision on November 21, 1995 after a review of 222 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5850 - 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 Prizm Medical, Inc. devices

FDA 510(k) Submission Details - K951727

510(k) Number K951727 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received April 13, 1995
Decision Date November 21, 1995
Days to Decision 222 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
107d slower than avg
Panel avg: 115d · This submission: 222d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IPF Device Classification - Class 2, Special Controls

Product Code IPF Stimulator, Muscle, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5850
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 Physical Medicine devices follow this clearance model.

Regulatory Peers - IPF Stimulator, Muscle, Powered

All 229
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