Cleared Traditional

K261887 - Normatec Elite Heat (PRO26-SH)

Also marketed or referenced as:
Normatec Elite Heat (PRO26-ST) Normatec Elite Heat (PRO26-TL) Normatec Elite Heat (PRO26-PH) Normatec Elite Heat (PRO26-PS) Normatec Elite Heat (PRO26-PT)

K261887 is an FDA 510(k) clearance for Normatec Elite Heat (PRO26-SH), manufactured by NormaTec Industries, LP. The device is a Class 2 Physical Medicine device with product code IRP cleared through the Traditional 510(k) pathway after a 123-day FDA review.

K261887 · NormaTec Industries, LP · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2026
Decision
123d
Days
Class 2
Risk

K261887 is an FDA 510(k) clearance for the Normatec Elite Heat (PRO26-SH). Classified as Massager, Powered Inflatable Tube (product code IRP), Class II - Special Controls.

Submitted by NormaTec Industries, LP (Watertown, US). The FDA issued a Cleared decision on October 6, 2026 after a review of 123 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5650 - 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 - K261887

510(k) Number K261887 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 2026
Decision Date October 06, 2026
Days to Decision 123 days
Submission Type Traditional
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
7d slower than avg
Panel avg: 116d · This submission: 123d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IRP Device Classification - Class 2, Special Controls

Product Code IRP Massager, Powered Inflatable Tube
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5650
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 Consultant

ProMedic, LLC
Matt Dryden

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - IRP Massager, Powered Inflatable Tube

All 157
Devices cleared under the same product code (IRP) and FDA review panel - the closest regulatory comparables to K261887.
Air compression massager (ACM-C1, ACM-C2, ACM-C3, ACM-C4, ACM-C5, ACM-C6, ACM-C7, ACM-C8, ACM-C9, ACM-5C1, ACM-5C2, ACM-5C3, ACM-5C4, ACM-5C5, ACM-5C6, ACM-5C7, ACM-5C8, ACM-5C9)
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ManaCold Compression System
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Air Compression Massager (HY-1165)
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Air Compression Massager (EP30B001 I)
K260948 · Wavepulse (Xiamen) Healthcare Technology Co., Ltd. · Jul 2026
Cryo And Thermo Therapy System
K253919 · Xiamen Weiyou Intelligent Technology Co., Ltd. · Jun 2026
Cryo Sport 2.0 (AVA 501)
K252396 · Avanutri Equipamentos DE Saúde · May 2026
K261887 · Normatec Elite Heat (PRO26-SH)
Download PDF FDA Summary NormaTec Industries, …