Cleared Traditional

K882669 - APPOLLO BATH

K882669 is an FDA 510(k) clearance for APPOLLO BATH, manufactured by Electric Mobility Corp.. The device is a Class 2 Physical Medicine device with product code ILK cleared through the Traditional 510(k) pathway after a 11-day FDA review.

K882669 · Electric Mobility Corp. · Physical Medicine device
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Jul 1988
Decision
11d
Days
Class 2
Risk

K882669 is an FDA 510(k) clearance for the APPOLLO BATH. Classified as Transport, Patient, Powered (product code ILK), Class II - Special Controls.

Submitted by Electric Mobility Corp. (Sewell, US). The FDA issued a Cleared decision on July 8, 1988 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 890.5150 - 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 - K882669

510(k) Number K882669 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 1988
Decision Date July 08, 1988
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.

ILK Device Classification - Class 2, Special Controls

Product Code ILK Transport, Patient, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5150
Definition A Powered Patient Transport Is A Motorized Device Intended For Use In Mitigating Mobility Impairment Caused By Injury Or Other Disease By Moving A Person From One Location Or Level To Another, Such As Up And Down Flights Of Stairs (e.g., Attendant-operated Portable Stair-climbing Chairs). This Generic Type Of Device Does Not Include Motorized Three-wheeled Vehicles Or Wheelchairs.
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 Consultant

Electric Mobility, LLC
Jordan Flowers

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - ILK Transport, Patient, Powered

All 35
Devices cleared under the same product code (ILK) and FDA review panel - the closest regulatory comparables to K882669.
LIBERTY SPECIAL AND LIBERTY STAIRLIFTS
K896628 · The Cheney Co. · Jan 1990
PATIENT MOVER(TM)
K890555 · T.B.S., Inc. · Feb 1989
LTDT PATIENT LIFTER
K884110 · Devine Medical Products · Oct 1988
STAIR VEYOR
K882091 · Pride Health Care, Inc. · May 1988
PATIENT MOVER(TM)
K871582 · T.B.S., Inc. · May 1987
BACK SAVER LIFT BELT/WHEELCHAIR TRANSFER DEVICE
K864152 · Lossing Orthopedic, Inc. · Feb 1987
K882669 · APPOLLO BATH
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