Cleared Traditional

K771967 - WHIRLPOOL BATH MODEL 2270

K771967 is an FDA 510(k) clearance for WHIRLPOOL BATH MODEL 2270, manufactured by Dazey Products Co.. The device is a Class 2 Physical Medicine device with product code ILJ cleared through the Traditional 510(k) pathway after a 11-day FDA review.

K771967 · Dazey Products Co. · Physical Medicine device
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Oct 1977
Decision
11d
Days
Class 2
Risk

K771967 is an FDA 510(k) clearance for the WHIRLPOOL BATH MODEL 2270. Classified as Bath, Hydro-massage (product code ILJ), Class II - Special Controls.

Submitted by Dazey Products Co. (Mchenry, US). The FDA issued a Cleared decision on October 28, 1977 after a review of 11 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K771967

510(k) Number K771967 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 1977
Decision Date October 28, 1977
Days to Decision 11 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
105d faster than avg
Panel avg: 116d · This submission: 11d
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 71
Devices cleared under the same product code (ILJ) and FDA review panel - the closest regulatory comparables to K771967.
TURBO-JET MODEL 76
K771969 · Dazey Products Co. · Nov 1977
WHIRLPOOL BATH MODEL 50
K771970 · Dazey Products Co. · Nov 1977
WHIRLPOOL BATH MODEL 2274
K771965 · Dozey Products Co. · Oct 1977
WHIRLPOOL BATH MODEL 2273
K771968 · Dazey Products Co. · Oct 1977
HYDROMASSAGE EQUIP. MODEL 1000
K771971 · Dazey Products Co. · Oct 1977
K771967 · WHIRLPOOL BATH MODEL 2270
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