(261 days)
Not Found
Not Found
No
The summary describes a simple heating pad with no mention of AI, ML, or any complex data processing.
Yes
The device is described as providing temporary relief of minor aches and pains, aiding in muscle relaxation, improving range of motion, and increasing local blood circulation, which are all therapeutic effects.
No
The device description and intended use indicate it is a therapeutic device (e.g., for pain relief, muscle relaxation, increased circulation), not for diagnosing conditions.
No
The device description explicitly states "Spinal Pad," which is a physical hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use and device description clearly indicate this is a physical device (Spinal Pad) applied externally to the body for therapeutic purposes (heat application, pain relief, muscle relaxation, increased circulation).
- There is no mention of analyzing biological samples. The description focuses on the physical effects of heat on muscles and joints.
- The intended use is for personal comfort and therapeutic relief. This aligns with a physical therapy or comfort device, not a diagnostic test.
The information provided describes a device that provides external physical therapy through heat, not a device that analyzes biological samples to diagnose or monitor a medical condition.
N/A
Intended Use / 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
- 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
Product codes
ILY
Device Description
Spinal Pad
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
muscles and joints
Indicated Patient Age Range
Not Found
Intended User / Care Setting
licensed medical professional
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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, (201) 594-4039. Additionally, for quest 22 (301) 594-4639. 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 (301) 443-6597 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 _