Cleared Traditional

K961621 - THERAPY CONCEPTS WATER CIRCULATING TREATMENT SYSTEM

K961621 is an FDA 510(k) clearance for THERAPY CONCEPTS WATER CIRCULATING TREA..., manufactured by Therapy Concepts, Inc.. The device is a Class 2 Physical Medicine device with product code ILO cleared through the Traditional 510(k) pathway after a 188-day FDA review.

K961621 · Therapy Concepts, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1996
Decision
188d
Days
Class 2
Risk

K961621 is an FDA 510(k) clearance for the THERAPY CONCEPTS WATER CIRCULATING TREATMENT SYSTEM. Classified as Pack, Hot Or Cold, Water Circulating (product code ILO), Class II - Special Controls.

Submitted by Therapy Concepts, Inc. (Chesterfield, US). The FDA issued a Cleared decision on October 31, 1996 after a review of 188 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5720 - 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 Therapy Concepts, Inc. devices

FDA 510(k) Submission Details - K961621

510(k) Number K961621 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 1996
Decision Date October 31, 1996
Days to Decision 188 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
73d slower than avg
Panel avg: 115d · This submission: 188d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ILO Device Classification - Class 2, Special Controls

Product Code ILO Pack, Hot Or Cold, Water Circulating
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5720
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 - ILO Pack, Hot Or Cold, Water Circulating

All 41
Devices cleared under the same product code (ILO) and FDA review panel - the closest regulatory comparables to K961621.
INCARE HOT/ICE SYSTEM SHOULDER BLANKET
K964057 · Hollister, Inc. · Dec 1996
POLAR CARE 300
K963596 · Breg, Inc. · Dec 1996
INCARE HOT/ICE LITE MACHINE
K962537 · Hollister, Inc. · Nov 1996
BIO COMPRESSION COLD FLO, SINGLE CHAMBER INTERMITTENT AND MULTI-CHAMBER SEQUENTIAL MODELS
K961425 · Bio Compression Systems, Inc. · Oct 1996
EBI THERMAL THERAPY SYSTEM
K963261 · Electro-Biology, Inc. · Sep 1996
POLAR CARE (MODEL 500/50000)
K961855 · Breg, Inc. · Aug 1996