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K Number
K971892
Device Name
BIOMEDICAL HORIZONS INC. COMPRESSION PUMP, MODEL 651
Manufacturer
BIOMEDICAL HORIZONS, INC.
Date Cleared
1998-08-05

(440 days)

Product Code
JOW
Regulation Number
870.5800
Type
Traditional
Panel
Cardiovascular
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Common Indications
Peripheral edema
Lymphedema (Postmastectomy, congenital)
Venous Stasis Ulcers
Stump reduction
Hand edema

Device Description

Compression Pump, Model 651

AI/ML Overview

I am sorry, but based on the provided document, I cannot answer your request. The document is a 510(k) clearance letter from the FDA for a compression pump and does not contain information about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment for a device's performance. It primarily focuses on the substantial equivalence determination for marketing the device.

§ 870.5800 Compressible limb sleeve.

(a)
Identification. A compressible limb sleeve is a device that is used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb.(b)
Classification. Class II (performance standards).