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K Number
K993684
Device Name
SPINAL PAD
Manufacturer
BIOSCAN, INC.
Date Cleared
2000-07-19

(261 days)

Product Code
ILY
Regulation Number
890.5500
Type
Traditional
Panel
PM
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
  • Use wherever hot applications are desirable for personal comfort and whenever recommended by a licensed medical professional
  • Provides temporary relief of minor aches and pains in muscles and joints
  • Aids in the relaxation of muscles
  • Helps provide for a temporary improved range and freedom of motion due to muscle relaxation and temporary minor pain relief
  • Provides a temporary increase in local blood circulation
Device Description

Spinal Pad

AI/ML Overview

I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA clearance letter for a device called "Spinal Pad" and outlines the indications for use. It does not include details about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set information.

§ 890.5500 Infrared lamp.

(a)
Identification. An infrared lamp is a device intended for medical purposes that emits energy at infrared frequencies (approximately 700 nanometers to 50,000 nanometers) to provide topical heating.(b)
Classification. Class II (special controls). The device, when it is an infrared therapeutic heating lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.