Cleared Traditional

K935868 - DYNAPHOR(TM) TWO

K935868 is an FDA 510(k) clearance for DYNAPHOR(TM) TWO, manufactured by Maxxim Medical. The device is a Class 2 Physical Medicine device with product code EGJ cleared through the Traditional 510(k) pathway after a 464-day FDA review.

K935868 · Maxxim Medical · Physical Medicine device
Download Printable Device Report (PDF)
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Mar 1995
Decision
464d
Days
Class 2
Risk

K935868 is an FDA 510(k) clearance for the DYNAPHOR(TM) TWO. Classified as Device, Iontophoresis, Other Uses (product code EGJ), Class II - Special Controls.

Submitted by Maxxim Medical (Sugar Land, US). The FDA issued a Cleared decision on March 15, 1995 after a review of 464 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5525 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Physical Medicine submissions.

View all Maxxim Medical devices

FDA 510(k) Submission Details - K935868

510(k) Number K935868 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 1993
Decision Date March 15, 1995
Days to Decision 464 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
349d slower than avg
Panel avg: 115d · This submission: 464d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EGJ Device Classification - Class 2, Special Controls

Product Code EGJ Device, Iontophoresis, Other Uses
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5525
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 - EGJ Device, Iontophoresis, Other Uses

All 30
Devices cleared under the same product code (EGJ) and FDA review panel - the closest regulatory comparables to K935868.
DUPEL IONTOPHORESIS SYSTEM
K991991 · Empi · Sep 1999
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K970491 · Empi · May 1997
MICROPHOR
K913601 · Life-Tech Intl., Inc. · Jul 1994
DUPEL IONTOPHORESIS DEVICE
K915444 · Empi · Jul 1994
TBD, EMPI BUFFERED IONTOPHORESIS ELECTRODED MDL. 3
K912015 · Empi · Nov 1991