Cleared Traditional

Power wheelchair (Model:BC-EA8000) (K232121) - FDA 510(k) Clearance

Class II Physical Medicine device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K232121 · Ningbo Baichen Medical Devices Co., Ltd. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2023
Decision
60d
Days
Class 2
Risk

K232121 is an FDA 510(k) clearance for the Power wheelchair (Model:BC-EA8000). Classified as Wheelchair, Powered (product code ITI), Class II - Special Controls.

Submitted by Ningbo Baichen Medical Devices Co., Ltd. (Ningbo, CN). The FDA issued a Cleared decision on September 15, 2023 after a review of 60 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3860 - 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 Ningbo Baichen Medical Devices Co., Ltd. devices

Submission Details

510(k) Number K232121 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 2023
Decision Date September 15, 2023
Days to Decision 60 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 115d · This submission: 60d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ITI Wheelchair, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.3860
Definition A Powered Wheelchair Is A Battery-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 Require An Assistive Device For Mobility. Note: This Type Of Device Is Not Intended To Climb Stairs (see Product Code: Imk).
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

Shanghai Sungo Management Consulting Company Limited.
Jarvis Wu

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 - ITI Wheelchair, Powered

All 138
Devices cleared under the same product code (ITI) and FDA review panel - the closest regulatory comparables to K232121.
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