Cleared Traditional

K842941 - MULTIPLE PLANETAMED

Also marketed or referenced as:
PLANETA HYDROMASS

K842941 is an FDA 510(k) clearance for MULTIPLE PLANETAMED, manufactured by Planeta Hausgeraete KG. The device is a Class 2 Physical Medicine device with product code ILJ cleared through the Traditional 510(k) pathway after a 9-day FDA review.

K842941 · Planeta Hausgeraete KG · Physical Medicine device
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Aug 1984
Decision
9d
Days
Class 2
Risk

K842941 is an FDA 510(k) clearance for the MULTIPLE PLANETAMED. Classified as Bath, Hydro-massage (product code ILJ), Class II - Special Controls.

Submitted by Planeta Hausgeraete KG (Mchenry, US). The FDA issued a Cleared decision on August 3, 1984 after a review of 9 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.

View all Planeta Hausgeraete KG devices

FDA 510(k) Submission Details - K842941

510(k) Number K842941 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 1984
Decision Date August 03, 1984
Days to Decision 9 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
106d faster than avg
Panel avg: 115d · This submission: 9d
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 14
Devices cleared under the same product code (ILJ) and FDA review panel - the closest regulatory comparables to K842941.
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