Cleared Traditional

K930670 - PHYACTION 787

K930670 is an FDA 510(k) clearance for PHYACTION 787, manufactured by Verimed Holdings, Inc.. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Traditional 510(k) pathway after a 143-day FDA review.

K930670 · Verimed Holdings, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1993
Decision
143d
Days
Class 2
Risk

K930670 is an FDA 510(k) clearance for the PHYACTION 787. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Verimed Holdings, Inc. (Fort Lauderdale, US). The FDA issued a Cleared decision on July 2, 1993 after a review of 143 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K930670

510(k) Number K930670 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 1993
Decision Date July 02, 1993
Days to Decision 143 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
27d slower than avg
Panel avg: 116d · This submission: 143d
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 547
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K930670.
STAODYN EMS+2
K926510 · Staodyne, Inc. · Aug 1993
THERAPEUTIC STIM 200 (TS-200)/200P (TS-200P)
K932399 · Myo/Kinetic Systems, Inc. · Aug 1993
NEURO-CARE 1000
K926265 · Ems Northwest · Aug 1993
PMP MUSCLE STIMULATOR
K924699 · Preferred Medical Products · Apr 1993
BIPHASIC UNIT
K923498 · Willows Health Center · Mar 1993
HIGH VOLT UNIT
K923501 · Willows Health Center · Mar 1993
K930670 · PHYACTION 787
Download PDF Verimed Holdings, Inc.