Cleared Traditional

K810275 - GRAB BARS

K810275 is the FDA 510(k) clearance for GRAB BARS by Maddak, Inc.. It is a Class 1 Physical Medicine device (product code IKX) cleared through the Traditional 510(k) pathway after a 10-day FDA review.

K810275 · Maddak, Inc. · Physical Medicine device
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Feb 1981
Decision
10d
Days
Class 1
Risk

K810275 is an FDA 510(k) clearance for the GRAB BARS. Classified as Aid, Transfer (product code IKX), Class I - General Controls.

Submitted by Maddak, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 12, 1981 after a review of 10 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5050 - 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 Maddak, Inc. devices

Submission Details

510(k) Number K810275 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 1981
Decision Date February 12, 1981
Days to Decision 10 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: 115d · This submission: 10d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IKX Aid, Transfer
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.5050
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 - IKX Aid, Transfer

All 10
Devices cleared under the same product code (IKX) and FDA review panel - the closest regulatory comparables to K810275.
BK-6111 HI-D TRANSFER BOARD
K813629 · Fred Sammons, Inc. · Jan 1982
TRANSFER BENCH
K812475 · Maddak, Inc. · Sep 1981
TRANSFER AIDS
K810449 · Fred Sammons, Inc. · Mar 1981
BOARD, TRANSFER, FENDER
K781201 · Fred Sammons, Inc. · Jul 1978
GRAB BAR
K780935 · Orthopedic Equipment Co., Inc. · Jun 1978
SLIDING BOARD
K772417 · Fred Sammons, Inc. · Jan 1978