Cleared Abbreviated

K050921 - EASYSTIM NMS-28

K050921 is an FDA 510(k) clearance for EASYSTIM NMS-28, manufactured by Easy Med Instrument Co., Ltd.. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Abbreviated 510(k) pathway after a 243-day FDA review.

K050921 · Easy Med Instrument Co., Ltd. · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2005
Decision
243d
Days
Class 2
Risk

K050921 is an FDA 510(k) clearance for the EASYSTIM NMS-28. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Easy Med Instrument Co., Ltd. (Guangdong, CN). The FDA issued a Cleared decision on December 12, 2005 after a review of 243 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5850 - the FDA physical medicine device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K050921

510(k) Number K050921 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 2005
Decision Date December 12, 2005
Days to Decision 243 days
Submission Type Abbreviated
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
127d slower than avg
Panel avg: 116d · This submission: 243d
Pathway characteristics
Standards-based clearance path.

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 367
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