Cleared Traditional

K101716 - HVR PAIN RELIEF DEVICE

K101716 is an FDA 510(k) clearance for HVR PAIN RELIEF DEVICE, manufactured by H.V.R., Inc.. The device is a Class 2 Physical Medicine device with product code ILY cleared through the Traditional 510(k) pathway after a 207-day FDA review.

K101716 · H.V.R., Inc. · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2011
Decision
207d
Days
Class 2
Risk

K101716 is an FDA 510(k) clearance for the HVR PAIN RELIEF DEVICE. Classified as Lamp, Infrared, Therapeutic Heating (product code ILY), Class II - Special Controls.

Submitted by H.V.R., Inc. (Van Nuys, US). The FDA issued a Cleared decision on January 11, 2011 after a review of 207 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5500 - 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 - K101716

510(k) Number K101716 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 2010
Decision Date January 11, 2011
Days to Decision 207 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
91d slower than avg
Panel avg: 116d · This submission: 207d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ILY Device Classification - Class 2, Special Controls

Product Code ILY Lamp, Infrared, Therapeutic Heating
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5500
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 - ILY Lamp, Infrared, Therapeutic Heating

All 220
Devices cleared under the same product code (ILY) and FDA review panel - the closest regulatory comparables to K101716.
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LITECURE THERAPY SYSTEM
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GAUNYING INFRARED LAMP MODEL IL50
K101693 · Foshan Gaunying Electronics Co., Ltd. · Jan 2011
MODEL LA-1200 MULTI-CHANNEL LASER THERAPY SYSTEM
K102134 · United Integrated Services Co., Ltd. · Dec 2010
PREMIO 10 MOXA
K101267 · Sedatelec · Dec 2010
K101716 · HVR PAIN RELIEF DEVICE
Download PDF FDA Summary H.V.R., Inc.