Cleared Traditional

K201547 - B&J DVT Foot Garments

K201547 is an FDA 510(k) clearance for B&J DVT Foot Garments, manufactured by B&J Manufacturing , Ltd.. The device is a Class 2 Cardiovascular device with product code JOW cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K201547 · B&J Manufacturing , Ltd. · Cardiovascular device
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Sep 2020
Decision
101d
Days
Class 2
Risk

K201547 is an FDA 510(k) clearance for the B&J DVT Foot Garments, Models 820 Series. Classified as Sleeve, Limb, Compressible (product code JOW), Class II - Special Controls.

Submitted by B&J Manufacturing , Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on September 18, 2020 after a review of 101 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5800 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all B&J Manufacturing , Ltd. devices

FDA 510(k) Submission Details - K201547

510(k) Number K201547 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 2020
Decision Date September 18, 2020
Days to Decision 101 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 125d · This submission: 101d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JOW Device Classification - Class 2, Special Controls

Product Code JOW Sleeve, Limb, Compressible
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5800
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 Cardiovascular devices follow this clearance model.

Regulatory Consultant

Shenzhen Joyantech Consulting Co., Ltd.
Fu Ailing

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 - JOW Sleeve, Limb, Compressible

All 115
Devices cleared under the same product code (JOW) and FDA review panel - the closest regulatory comparables to K201547.
Flexitouch Plus System
K203178 · Tactile Systems Technology, Inc. (Dba Tactile Medical) · Dec 2020
DVT-2600
K203016 · Daesung Maref Co., Ltd. · Dec 2020
B&J DVT Calf/Thigh Garments, Models 801/830 Series
K201532 · B&J Manufacturing , Ltd. · Sep 2020
VariLymph 12 pro
K193476 · Slk Medical GmbH · Aug 2020
ManaFlow
K200353 · Manamed, Inc. · Aug 2020
B&J MHP800 Deep Vein Thrombosis (DVT) Prevention System
K200568 · B&J Manufacturing , Ltd. · Jul 2020