Cleared Traditional

K201196 - Scooter (Model: FDB01) (FDA 510(k) Clearance)

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

K201196 · Nanjing Jin Bai HE Medical Apparatus Co., Ltd. · Physical Medicine device
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Jun 2021
Decision
417d
Days
Class 2
Risk

K201196 is an FDA 510(k) clearance for the Scooter (Model: FDB01). Classified as Vehicle, Motorized 3-wheeled (product code INI), Class II - Special Controls.

Submitted by Nanjing Jin Bai HE Medical Apparatus Co., Ltd. (Nanjing, CN). The FDA issued a Cleared decision on June 25, 2021 after a review of 417 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3800 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Physical Medicine submissions.

View all Nanjing Jin Bai HE Medical Apparatus Co., Ltd. devices

Submission Details

510(k) Number K201196 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 2020
Decision Date June 25, 2021
Days to Decision 417 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
302d slower than avg
Panel avg: 115d · This submission: 417d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code INI Vehicle, Motorized 3-wheeled
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.3800
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 Co., Ltd.
Ivy Wang

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 - INI Vehicle, Motorized 3-wheeled

All 343
Devices cleared under the same product code (INI) and FDA review panel - the closest regulatory comparables to K201196.
Mobility Scooter (X-12, X-14, X-17)
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Electrical Scooter (SM4226)
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Mobility Scooter (CL-Q3, CL-Q4)
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Mobility Scooter (S3)
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Electric Scooter (DDF100)
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