Cleared Traditional

K974321 - HYDROTONE

K974321 is an FDA 510(k) clearance for HYDROTONE, manufactured by North American Technical Services Corp.. The device is a Class 2 Physical Medicine device with product code ILJ cleared through the Traditional 510(k) pathway after a 217-day FDA review.

K974321 · North American Technical Services Corp. · Physical Medicine device
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Jun 1998
Decision
217d
Days
Class 2
Risk

K974321 is an FDA 510(k) clearance for the HYDROTONE. Classified as Bath, Hydro-massage (product code ILJ), Class II - Special Controls.

Submitted by North American Technical Services Corp. (Sound Beach, US). The FDA issued a Cleared decision on June 22, 1998 after a review of 217 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5100 - 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 - K974321

510(k) Number K974321 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 1997
Decision Date June 22, 1998
Days to Decision 217 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
101d slower than avg
Panel avg: 116d · This submission: 217d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ILJ Device Classification - Class 2, Special Controls

Product Code ILJ Bath, Hydro-massage
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5100
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 - ILJ Bath, Hydro-massage

All 35
Devices cleared under the same product code (ILJ) and FDA review panel - the closest regulatory comparables to K974321.
HYDROTONE-THERMAL CAPSULE SYSTEM
K991184 · Nats Corp. · Jun 1999
VICHY SHOWER
K980909 · Bouvier Hydro, Inc. · Aug 1998
EQUINOXE
K980920 · Bouvier Hydro, Inc. · Jul 1998
FERNO HEALTHCARE RECLINE-A-BATH 2
K980033 · Ferno-Washington, Inc. · Apr 1998
WINDMERE MODEL DS-2 FOOT BATH
K980769 · Windmere Corp. · Mar 1998
XTANK2 MOBILE EXTREMITY WHIRLPOOL SYSTEM
K971592 · The Silcraft Corp. · Feb 1998
K974321 · HYDROTONE
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