Cleared Traditional

K913998 - PAM PLUS

K913998 is an FDA 510(k) clearance for PAM PLUS, manufactured by Kinetic Concepts, Inc.. The device is a Class 1 Physical Medicine device with product code IRO cleared through the Traditional 510(k) pathway after a 124-day FDA review.

K913998 · Kinetic Concepts, Inc. · Physical Medicine device
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Jan 1992
Decision
124d
Days
Class 1
Risk

K913998 is an FDA 510(k) clearance for the PAM PLUS. Classified as Vibrator, Therapeutic (product code IRO), Class I - General Controls.

Submitted by Kinetic Concepts, Inc. (San Antonio, US). The FDA issued a Cleared decision on January 8, 1992 after a review of 124 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5975 - 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 Kinetic Concepts, Inc. devices

FDA 510(k) Submission Details - K913998

510(k) Number K913998 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 1991
Decision Date January 08, 1992
Days to Decision 124 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
9d slower than avg
Panel avg: 115d · This submission: 124d
Pathway characteristics
Predicate-based equivalence.

IRO Device Classification - Class 1, General Controls

Product Code IRO Vibrator, Therapeutic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.5975
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - IRO Vibrator, Therapeutic

All 19
Devices cleared under the same product code (IRO) and FDA review panel - the closest regulatory comparables to K913998.
HEALTH ESSENTIALS BODY CARE MASSAGER
K924582 · Conair Corp. · Oct 1993
HEALTH ESSENTIALS MULTI-PURPOSE MASSAGER
K924583 · Conair Corp. · Oct 1993
HEALTH ESSENTIALS FANCY PERSONAL MASSAGER
K924584 · Conair Corp. · Oct 1993
TOUCH N TONE 1 MASSAGER
K915242 · Conair Corp. · Dec 1991
MULTI-REACH II WAND MASSAGER
K914344 · Conair Corp. · Oct 1991
VASOTRAIN 447
K871107 · Henley Intl. · May 1987