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FDA 510(k)

Teeter 手动倒立床;Teeter 重力靴;Teeter 前倾减压设备;Teeter 便携式减压设备;Teeter 水平减压床

K号: K162702 · 2016-12-30

决定日期2016-12-30
产品代码HST
咨询委员会OR 请注意,由于原文中未提供具体的医疗设备监管文本,以下是一个示例翻译,您可以根据实际文本进行调整: --- 产品名称:[产品名称] 公司名称:[公司名称] 根据FDA 510(k)预市场批准程序,[产品名称]已获得批准,用于[产品用途描述]。 产品注册号:[注册号] PMA编号:[PMA编号] 临床试验编号(NCT):[NCT编号] PubMed ID(PMID):[PMID编号] 更多信息请访问以下链接: [URL] --- 请将上述示例中的[产品名称]、[公司名称]、[注册号]、[PMA编号]、[NCT编号]、[PMID编号]和[URL]替换为实际的文本内容。
决定实质等同

器械摘要

Teeter Manual Inversion Table; Teeter Gravity Boots; Teeter Forward Rotation Decompression Device; Teeter Portable Decompression Device; Teeter Horizontal Decompression Table is the device name listed in this FDA 510(k) record. The listed applicant is Stl International, Inc.. It received FDA 510(k) clearance on 2016-12-30 under 510(k) number K162702. The device is classified under product code HST. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Teeter Manual Inversion Table; Teeter Gravity Boots; Teeter Forward Rotation Decompression Device; Teeter Portable Decompression Device; Teeter Horizontal Decompression Table?

Teeter Manual Inversion Table; Teeter Gravity Boots; Teeter Forward Rotation Decompression Device; Teeter Portable Decompression Device; Teeter Horizontal Decompression Table is a medical device that received FDA 510(k) clearance on 2016-12-30. The listed applicant is Stl International, Inc.. The 510(k) number is K162702.

When did Teeter Manual Inversion Table; Teeter Gravity Boots; Teeter Forward Rotation Decompression Device; Teeter Portable Decompression Device; Teeter Horizontal Decompression Table receive FDA 510(k) clearance?

Teeter Manual Inversion Table; Teeter Gravity Boots; Teeter Forward Rotation Decompression Device; Teeter Portable Decompression Device; Teeter Horizontal Decompression Table received FDA 510(k) clearance on 2016-12-30, under 510(k) number K162702.

Who is the listed applicant for Teeter Manual Inversion Table; Teeter Gravity Boots; Teeter Forward Rotation Decompression Device; Teeter Portable Decompression Device; Teeter Horizontal Decompression Table?

The FDA 510(k) record lists Stl International, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Teeter Manual Inversion Table; Teeter Gravity Boots; Teeter Forward Rotation Decompression Device; Teeter Portable Decompression Device; Teeter Horizontal Decompression Table?

The FDA product code for Teeter Manual Inversion Table; Teeter Gravity Boots; Teeter Forward Rotation Decompression Device; Teeter Portable Decompression Device; Teeter Horizontal Decompression Table is HST.

相关临床试验

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