WOUND CARE COMPRESSION SYSTEM (WCCS)

• K Number: K960585
• Device Name: WOUND CARE COMPRESSION SYSTEM (WCCS)
• Manufacturer: SUNCOAST MEDICAL PRODUCTS, INC.
• Date Cleared: 1996-04-26 ( 74 days)
• Product Code: MCY
• Regulation Number: 880.5075
• Type: Traditional
• Panel: General & Plastic Surgery
• Age Range: N/A
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

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Device Description

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AI/ML Overview

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Summary

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Regulation Number and Section

§ 880.5075 Elastic bandage.

(a)
Identification. An elastic bandage is a device consisting of either a long flat strip or a tube of elasticized material that is used to support and compress a part of a patient's body.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9. The device also is exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.