Cleared Traditional

K062631 - MYOMO E100

K062631 is an FDA 510(k) clearance for MYOMO E100, manufactured by Myomo, Inc.. The device is a Class 2 Physical Medicine device with product code OAL cleared through the Traditional 510(k) pathway after a 219-day FDA review.

K062631 · Myomo, Inc. · Physical Medicine device
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Optimized for regulatory review, auditing and printing
Apr 2007
Decision
219d
Days
Class 2
Risk

K062631 is an FDA 510(k) clearance for the MYOMO E100. Classified as Exercise Equipment, Powered, Emg-triggered (product code OAL), Class II - Special Controls.

Submitted by Myomo, Inc. (Boston, US). The FDA issued a Cleared decision on April 12, 2007 after a review of 219 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.1375 - 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 Myomo, Inc. devices

FDA 510(k) Submission Details - K062631

510(k) Number K062631 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 2006
Decision Date April 12, 2007
Days to Decision 219 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
104d slower than avg
Panel avg: 115d · This submission: 219d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OAL Device Classification - Class 2, Special Controls

Product Code OAL Exercise Equipment, Powered, Emg-triggered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.1375
Definition To Provide Rehabilitation (e.g., Increasing Range Of Motion, Muscle Re-education) Through Emg-triggered Powered Exercise. Increasing Range Of Motion And Muscle Re-education.
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.