Cleared Traditional

K233536 - Air Compression Recovery System (FDA 510(k) Clearance)

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

K233536 · Shenzhen Dongjilian Medical Tech Co., Ltd. · Physical Medicine device
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Dec 2023
Decision
43d
Days
Class 2
Risk

K233536 is an FDA 510(k) clearance for the Air Compression Recovery System. Classified as Massager, Powered Inflatable Tube (product code IRP), Class II - Special Controls.

Submitted by Shenzhen Dongjilian Medical Tech Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on December 16, 2023 after a review of 43 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5650 - 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 Shenzhen Dongjilian Medical Tech Co., Ltd. devices

Submission Details

510(k) Number K233536 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 2023
Decision Date December 16, 2023
Days to Decision 43 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 115d · This submission: 43d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IRP Massager, Powered Inflatable Tube
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5650
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 Peers - IRP Massager, Powered Inflatable Tube

All 149
Devices cleared under the same product code (IRP) and FDA review panel - the closest regulatory comparables to K233536.
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AIR COMPRESSION BOOTS 1018195,1018196
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