SPINAL PAD

K993684 · Bioscan, Inc. · ILY · Jul 19, 2000 · Physical Medicine

Device Facts

• Record ID: K993684
• Device Name: SPINAL PAD
• Applicant: Bioscan, Inc.
• Product Code: ILY · Physical Medicine
• Decision Date: Jul 19, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5500
• Device Class: Class 2
• Attributes: Therapeutic

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 Story

Spinal Pad is a thermal therapy device providing heat application for musculoskeletal relief. Device operates by delivering localized heat to muscles and joints; intended to facilitate muscle relaxation, improve range of motion, and increase local blood circulation. Used in home or clinical settings by patients or under professional guidance. Output is thermal energy; healthcare providers use device to manage minor aches and pains. Benefits include temporary pain relief and improved mobility through heat-induced relaxation.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Thermal therapy device; form factor designed for spinal application. Operates via heat generation for local circulation and muscle relaxation. No software, connectivity, or complex electronic components described.

Indications for Use

Indicated for individuals seeking temporary relief of minor muscle and joint aches and pains, muscle relaxation, improved range of motion, and increased local blood circulation. Suitable for personal comfort or as recommended by a licensed medical professional.

Regulatory Classification

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.

Special Controls

*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.

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling three overlapping human profiles or silhouettes, with flowing lines suggesting movement or connection.

JUL 1 9 2000

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Butch Smith, Vice President BioScan, Inc. 6 Walden Road Corrales, New Mexico 87048

Re: K993684 Trade Name: Spinal Pad Regulatory Class: II Product Code: ILY Dated: April 5, 2000 Received: April 27, 2000

Dear Mr. Smith:

We have reviewed your Section 510(k) notification of intent to market the device referenced we have reviewed your Seculi > ro(x) notificantially equivalent (for the indications for use above and we nave decemined the active is eadinate devices marketed in interstate commerce stated in the enclosure) to legally markets procession in the Medical Device Amendments, or to devices that prior to May 26, 1770, the chaolinen with the provisions of the Federal Food, Drug, and have been reclassified in accordance fire, market the device, subject to the general controls Cosment Act (Act). Tournaly, morelor, increise, include requirements for provisions of the Act. The general control province, labeling, and probibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III If your device is classified (500 acc royal additional controls. Existing major regulations (Fremarket Approvar), it may of stores of Federal Regulations, Title 21, Parts 800 to allecting your device call of route entination assumes compliance with the Current Good 097. A Substantially Cqurvaions as set forth in the Quality System Regulation (QS) for Manufacturing Fractive requation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to mspections, the rood and Drug Nammountin to regulatory action. In addition, FDA may publish Comply with the GMI Togaration may ur device in the Federal Register. Please note: this response to your premarks botification submission does not affect any obligation you might It sponse to your premanter nombours the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

{1}------------------------------------------------

## Page 2 - Butch Smith

This letter will allow you to begin marketing your device as described in your 510(k) premarket I his letter will anow you to ocelli marketing your device to a legally marketed notification. The PDA inding of successification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFF Part 801 and If you desire specific advice for your actives), please contact the Office of Compliance at additionally 809.10 for in Vitto diagnostions on the promotion and advertising of your device, [phone]. Additionally, for quest 22 [phone]. Also, please note the regulation prease conact the Office or Comphans to premarket notification" (21CFR 807.97). Other general entitled, "Wissuranumig by reference to prema. Act reasy be obtained from the Division of Small
information on your responsibilities under the 2011 - 10:14 AM2 (607 - 16.1) information on your responsibilities and in the received or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Donne R. Vochner

Celia M. Witten, Ph.D., M.D. Director

Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

## 510(k) Number (if known): K993684

Device Name: Spinal Pad

Indications for 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
- A 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

## (PLEASE DO NOT WITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use: (Per 21 CFR 801.109) OR

Over the Counter Use: (Optional Format 1-2-96)

Daine R. lochner

(Division Sign-Off) Division of General Restorative Deyicas 8993 ((k) Number _