Cleared Traditional

K822250 - MYO-TONE, INC. SYSTEM-80

K822250 is an FDA 510(k) clearance for MYO-TONE, manufactured by Myo-Tone, Inc.. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K822250 · Myo-Tone, Inc. · Physical Medicine device
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Sep 1982
Decision
57d
Days
Class 2
Risk

K822250 is an FDA 510(k) clearance for the MYO-TONE, INC. SYSTEM-80. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Myo-Tone, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 22, 1982 after a review of 57 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K822250

510(k) Number K822250 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 1982
Decision Date September 22, 1982
Days to Decision 57 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 116d · This submission: 57d
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 529
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K822250.
BX-500 ELECTRONIC MUSCLE EXERCISER
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K822519 · A-Zenith Therapeutic Equipment/Supply · Oct 1982
EXER-STIM CONTROLLER
K822056 · Th Charters, Inc. · Oct 1982
COMPLY NEUROMUSCULAR STIMULATOR
K822284 · Omega-Med Intl., Inc. · Sep 1982
EF2000
K820953 · Squire, Sanders & Dempsey · Jul 1982
P6S ATHLETIC
K821449 · Squire, Sanders & Dempsey · Jul 1982
K822250 · MYO-TONE, INC. SYSTEM-80
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