K Number

Device Name

MODEL 2200

Manufacturer

CLARIMEDEX, INC.

Date Cleared

2006-12-19

(104 days)

Product Code

ILY

Regulation Number

890.5500

Intended Use

The CLARIMEDIX device is indicated for use to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting relaxation of muscle tissue; and to temporarily increase blood circulation where applied.

Device Description

The system is a self-contained unit with four treatment areas. - . Popliteal treatment zone - Calf treatment zone . - Foot treatment zone . - . Heel treatment zone

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K032229, K931261

Reference Devices

K032229, K931261

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary does not mention AI, ML, or related concepts like deep learning, training sets, or performance metrics typically associated with AI/ML devices. The device description focuses on the physical characteristics and intended use of infrared heating.

Therapeutic

Yes
The device is indicated for therapeutic purposes, including temporary relief of pain (muscle, joint, and arthritis), muscle spasm, stiffness, promoting muscle relaxation, and temporarily increasing blood circulation. These are all therapeutic outcomes.

Diagnostic

No
The device is indicated for therapeutic purposes (topical heating, pain relief, circulation increase) and does not mention any function for diagnosing conditions.

SaMD (Software as a Medical Device)

The device description explicitly states it is a "self-contained unit with four treatment areas" and emits energy in the infrared spectrum, indicating it is a hardware device with physical components, not software only.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
CLARIMEDIX Function: The CLARIMEDIX device described here applies infrared energy directly to the body for therapeutic purposes (heating tissue, relieving pain, increasing circulation). It does not analyze any specimens taken from the body.

The intended use and device description clearly indicate a therapeutic device, not a diagnostic one.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The device is indicated for use for the treatment of chronic pain by emitting energy in the IR spectrum for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffiess; promoting relaxation of muscle tissue; and to temporarily increase local blood circulation where applied

Product codes

ILY

Device Description

The system is a self-contained unit with four treatment areas.

. Popliteal treatment zone
Calf treatment zone .
Foot treatment zone .
. Heel treatment zone

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Popliteal treatment zone, Calf treatment zone, Foot treatment zone, Heel treatment zone, Lower leg, foot, adjustable location

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Physical medicine health care professionals / Medical health care facilities

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)

K032229, K931261

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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.

Summary

K062635

510(k) Summary Prepared August 5, 2006

| Submitted by: | CLARIMEDIX, Inc.
1035 Pearl Street, Suite 400
Boulder, Colorado 80302 | | |
|-----------------|-----------------------------------------------------------------------------|-------------------------------------------------------------|--------------|
| Contact Person: | John Dunning
President
Telephone:
FAX:
e-mail: | (303) 905 6163
(303) 625 1030
jdunning@clarimedix.com | DEC 1 9 2006 |
| Product Name: | Model 2200 System | | |
| Common Name: | Infrared lamp | | |
| Classification: | ILY; Class II; CFR 21 890.5500 | | |

Predicate Devices:

Device Name	Manufacturer	K Number
Warp 10	Quantum Devices	K032229
Spectropad
(a.k.a.
Restorative
Products, Inc.)	SMI (A.k.a. Anodyne
Therapy System)	K931261

Description of Device:

The system is a self-contained unit with four treatment areas.

. Popliteal treatment zone
Calf treatment zone .
Foot treatment zone .
. Heel treatment zone

Intended Use:

The device is indicated for use for the treatment of chronic pain by emitting energy in the IR spectrum for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting relaxation of muscle tissue; and to temporarily increase local blood circulation where applied

Comparison with Predicate Devices:

The submission device and the predicate devices have substantially equivalent intended use and technological specifications as shown in the tables below. The device is compliant with the standards for electrical safety and EMC, IEC 60601-1 IEC 60601-1-2 respectively.

	Predicate Devices		Subject Device
	Quantum Warp 10
K032229	SMI Spectropad
K931261
(a.k.a. Anodyne Therapy
System)	CLARIMEDIX Model 2200
FDA
classification	21 CFR 890.5500 Infrared
Lamp (ILY)
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	21 CFR 890.5500 Infrared
Lamp (ILY)
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	21 CFR 890.5500 Infrared
Lamp (ILY)
a) The CLARIMEDIX device
is indicated for use to emit
energy in the infrared
spectrum to provide topical
heating for the purpose of
elevating tissue temperature;
for the temporary relief of
minor muscle and joint pain,
arthritis and muscle spasm;
relieving stiffness; promoting
relaxation of muscle tissue;
and to temporarily increase
blood circulation where
applied.
b) classification Class II
Intended Use	Indicated for use for the
treatment of chronic pain by
emitting energy in the Near-IR
spectrum for the temporary
relief of minor muscle and joint
pain, arthritis and muscle
spasm; relieving stiffness;
promoting relaxation of muscle
tissue; and to temporarily
increase local blood circulation
where applied	Intended for relief of minor
muscle and joint pain and
improvement of superficial
circulation 1	indicated for use for the
treatment of chronic pain by
emitting energy in the IR
spectrum for the temporary
relief of minor muscle and
joint pain, arthritis and muscle
spasm; relieving stiffness;
promoting relaxation of muscle
tissue; and to temporarily
increase local blood circulation
where applied
Intended
Users	Physical medicine health care
professionals	Physical medicine health care
professionals	Physical medicine health care
professionals
Intended Site
of Use	Medical health care facilities	Medical health care facilities	Medical health care facilities

Table 1 Comparison of Indications for Use

	Predicate Devices	Predicate Devices	Subject Device
	Quantum Warp 10
K032229	SMI Spectropad
K931261
(a.k.a. Anodyne Therapy
System)	CLARIMEDIX Model 2200
Method of
administration	Topical	Topical	Topical
Treatment areas	10cm2	Leg, foot, arm, neck	Lower leg, foot, adjustable
location
Number of
zones	Not specified in product
labeling	4-8 therapy pads	Four zones
Temperature at
the skin surface	Not specified in labeling	Not specified in labeling	Less than 95° F
Energy source	Multidiodes dispersed over
treatment zones	60 Infrared diodes per array	Multidiodes
Waveform	Constant	Not specified in labeling	Modulating
Power supply	8 each 1.5 AA batteries
provides 50 doses	Not specified in labeling	24V
Safety features	Remains cool to the touch	Not specified in labeling	Remains cool to touch
Biocompatibility	Not specified in labeling	Not specified in labeling;	Biocompatible drape
recommended
Configuration	Handheld	4-8 pads applied	4 zones applied
Length and
width	5.55in x 2.65 in	Not specified in labeling	25.1 in. x 10.0 in.
Portable	Yes	Yes	Yes
Electrical safety	Not specified in labeling	Not specified in labeling	Compliant with IEC 60601-1
Firmware
control	Yes	Yes	Yes

Table 2 Comparison of Technological Characteristics

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circular pattern around the symbol. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

CLARIMEDEX, Inc. % Regulatory Technology Services, LLC Mr. Mark Job 1394 25TH Street, Northwest Buffalo, Minnesota 55313

DEC 1 9 2006

Re: K062635

Trade/Device Name: Model 2200 Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: II Product Code: ILY Dated: December 6, 2006 Received: December 7, 2006

Dear Mr. Job:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Page 2 - Mr. Mark Job

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

For Pablo

Mark N. Melkerson

DEP D.R.SECTOR

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

Enclosure

510(k) Number (if known):

Device Name: Model 2200

Indications For Use:

X Prescription Use (Per 21CFR 801)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence Of CDRH, Office Of Device Evaluation (ODE)

(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices

(K) Number 2062635