Cleared Abbreviated

K991184 - HYDROTONE-THERMAL CAPSULE SYSTEM

K991184 is an FDA 510(k) clearance for HYDROTONE-THERMAL CAPSULE SYSTEM, manufactured by Nats Corp.. The device is a Class 2 Physical Medicine device with product code ILJ cleared through the Abbreviated 510(k) pathway after a 76-day FDA review.

K991184 · Nats Corp. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1999
Decision
76d
Days
Class 2
Risk

K991184 is an FDA 510(k) clearance for the HYDROTONE-THERMAL CAPSULE SYSTEM. Classified as Bath, Hydro-massage (product code ILJ), Class II - Special Controls.

Submitted by Nats Corp. (Sound Beach, US). The FDA issued a Cleared decision on June 23, 1999 after a review of 76 days - a notably fast clearance cycle.

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

View all Nats Corp. devices

FDA 510(k) Submission Details - K991184

510(k) Number K991184 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 1999
Decision Date June 23, 1999
Days to Decision 76 days
Submission Type Abbreviated
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
39d faster than avg
Panel avg: 115d · This submission: 76d
Pathway characteristics
Standards-based clearance path.

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 12
Devices cleared under the same product code (ILJ) and FDA review panel - the closest regulatory comparables to K991184.
MBATH 1000 (60)
K052479 · Enneking Medical, Inc. · Jan 2006
VANNA BATHING SYSTEM
K993872 · Vancare, Inc. · Feb 2000
A-2000 BATHING SYSTEMS
K992779 · Medi-Man Rehabilitation Products, Inc. · Jan 2000
VICHY SHOWER
K980909 · Bouvier Hydro, Inc. · Aug 1998
EQUINOXE
K980920 · Bouvier Hydro, Inc. · Jul 1998
HYDROTONE
K974321 · North American Technical Services Corp. · Jun 1998