Cleared Traditional

K101217 - MAC-MOBILE AQUATIC CHAIR

K101217 is an FDA 510(k) clearance for MAC-MOBILE AQUATIC CHAIR, manufactured by Rehamed Intl., LLC. The device is a Class 1 Physical Medicine device with product code IOR cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K101217 · Rehamed Intl., LLC · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2010
Decision
54d
Days
Class 1
Risk

K101217 is an FDA 510(k) clearance for the MAC-MOBILE AQUATIC CHAIR. Classified as Wheelchair, Mechanical (product code IOR), Class I - General Controls.

Submitted by Rehamed Intl., LLC (Homestead, US). The FDA issued a Cleared decision on June 23, 2010 after a review of 54 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3850 - 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 - K101217

510(k) Number K101217 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 2010
Decision Date June 23, 2010
Days to Decision 54 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 116d · This submission: 54d
Pathway characteristics
Predicate-based equivalence.

IOR Device Classification - Class 1, General Controls

Product Code IOR Wheelchair, Mechanical
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.3850
Definition A Mechanical Wheelchair Is A Manually Operated Device With Wheels That Is Intended For Medical Purposes To Provide Mobility To Persons Restricted To A Sitting Position. Fda Interprets “mobility To Persons Restricted To A Sitting Position” To Mean The Device Type Is Intended To Provide Mobility To Individuals Who Have Mobility Impairments And/or Require An Assistive Device For Mobility.
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 - IOR Wheelchair, Mechanical

All 424
Devices cleared under the same product code (IOR) and FDA review panel - the closest regulatory comparables to K101217.
KAIYANG ALUMINUM WHEELCHAIR
K101998 · Guangdong Kaiyang Medical Technology Co., Ltd. · Oct 2010
KAIYANG STEEL WHEELCHAIR
K101999 · Guangdong Kaiyang Medical Technology Co., Ltd. · Oct 2010
TACAMO MANUAL WHEELCHAIR
K101719 · Dalton Instrument Corp. · Aug 2010
ORION II (HEAVY DUTY 350 LBS AND 500 LBS)
K101277 · Future Mobility Healthcare, Inc. · Jun 2010
MECHANICAL WHEELCHAIR, MODEL DS 202-S
K100824 · Suzhou KD Medical · May 2010
MULTI FRAME WHEELCHAIR
K100084 · R82 A/S · Apr 2010
K101217 · MAC-MOBILE AQUATIC CHAIR
Download PDF FDA Summary Rehamed Intl., LLC