Cleared Traditional

K944885 - DH-1, DH-2, DH-3, DH-6, DH-68, DH-8, AMH-6, FM-10, FM-20, FM-30, FBM-1000, FBM-2000

K944885 is an FDA 510(k) clearance for DH-1, manufactured by Kolvin Industries , Ltd.. The device is a Class 1 Physical Medicine device with product code ISA cleared through the Traditional 510(k) pathway after a 134-day FDA review.

K944885 · Kolvin Industries , Ltd. · Physical Medicine device
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Feb 1995
Decision
134d
Days
Class 1
Risk

K944885 is an FDA 510(k) clearance for the DH-1, DH-2, DH-3, DH-6, DH-68, DH-8, AMH-6, FM-10, FM-20, FM-30, FBM-1000, FB.... Classified as Massager, Therapeutic, Electric (product code ISA), Class I - General Controls.

Submitted by Kolvin Industries , Ltd. (Kowloon, HK). The FDA issued a Cleared decision on February 14, 1995 after a review of 134 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5660 - 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 Kolvin Industries , Ltd. devices

FDA 510(k) Submission Details - K944885

510(k) Number K944885 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received October 03, 1994
Decision Date February 14, 1995
Days to Decision 134 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d slower than avg
Panel avg: 115d · This submission: 134d
Pathway characteristics
Predicate-based equivalence.

ISA Device Classification - Class 1, General Controls

Product Code ISA Massager, Therapeutic, Electric
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.5660
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - ISA Massager, Therapeutic, Electric

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