Cleared Traditional

K213097 - Armory Motion

K213097 is an FDA 510(k) clearance for Armory Motion, manufactured by Pain Management Technologies, Inc.. The device is a Class 2 Neurology device with product code ILO cleared through the Traditional 510(k) pathway after a 259-day FDA review.

K213097 · Pain Management Technologies, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2022
Decision
259d
Days
Class 2
Risk

K213097 is an FDA 510(k) clearance for the Armory Motion. Classified as Pack, Hot Or Cold, Water Circulating (product code ILO), Class II - Special Controls.

Submitted by Pain Management Technologies, Inc. (Akron, US). The FDA issued a Cleared decision on June 10, 2022 after a review of 259 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 890.5720 - the FDA neurology 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 Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Pain Management Technologies, Inc. devices

FDA 510(k) Submission Details - K213097

510(k) Number K213097 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 2021
Decision Date June 10, 2022
Days to Decision 259 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
111d slower than avg
Panel avg: 148d · This submission: 259d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ILO Device Classification - Class 2, Special Controls

Product Code ILO Pack, Hot Or Cold, Water Circulating
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5720
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 Neurology devices follow this clearance model.

Regulatory Peers - ILO Pack, Hot Or Cold, Water Circulating

All 25
Devices cleared under the same product code (ILO) and FDA review panel - the closest regulatory comparables to K213097.
T-PUMP LOCALIZED TEMPERATURE THERAPY PUMP
K073675 · Gaymar Industries, Inc. · May 2008
INCARE HOT/ICE SYSTEM FOOT/ANKLE BLANKET
K973023 · Hollister, Inc. · Nov 1997
MODEL 1100 COLD THERAPY DEVICE
K970533 · Smith & Nephew, Inc. · Apr 1997
INCARE HOT/ICE SYSTEM BLANKETS (VARIOUS SIZES AND SHAPES)
K964006 · Hollister, Inc. · Dec 1996
INCARE HOT/ICE SYSTEM SHOULDER BLANKET
K964057 · Hollister, Inc. · Dec 1996
INCARE HOT/ICE LITE MACHINE
K962537 · Hollister, Inc. · Nov 1996