Cleared Traditional

K934886 - NEXT WAVE PHYSIOACOUSTIC MATTRESS

K934886 is an FDA 510(k) clearance for NEXT WAVE PHYSIOACOUSTIC MATTRESS, manufactured by Next Wave, Inc.. The device is a Class 1 Physical Medicine device with product code IRO cleared through the Traditional 510(k) pathway after a 240-day FDA review.

K934886 · Next Wave, Inc. · Physical Medicine device
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Jun 1994
Decision
240d
Days
Class 1
Risk

K934886 is an FDA 510(k) clearance for the NEXT WAVE PHYSIOACOUSTIC MATTRESS. Classified as Vibrator, Therapeutic (product code IRO), Class I - General Controls.

Submitted by Next Wave, Inc. (Kalamazoo, US). The FDA issued a Cleared decision on June 9, 1994 after a review of 240 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5975 - 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 Next Wave, Inc. devices

FDA 510(k) Submission Details - K934886

510(k) Number K934886 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received October 12, 1993
Decision Date June 09, 1994
Days to Decision 240 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
125d slower than avg
Panel avg: 115d · This submission: 240d
Pathway characteristics
Predicate-based equivalence.

IRO Device Classification - Class 1, General Controls

Product Code IRO Vibrator, Therapeutic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.5975
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 - IRO Vibrator, Therapeutic

All 22
Devices cleared under the same product code (IRO) and FDA review panel - the closest regulatory comparables to K934886.
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