THERAPIK

K964397 · The Jenex Corporation · ILY · Nov 4, 1997 · Physical Medicine

Device Facts

• Record ID: K964397
• Device Name: THERAPIK
• Applicant: The Jenex Corporation
• Product Code: ILY · Physical Medicine
• Decision Date: Nov 4, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5500
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Therapik is indicated for use to provide temporary relief of the pain and itching resulting from insect stings and bites such as bees, wasps and mosquitoes by increasing localized blood flow.

Device Story

Therapik is a portable, hand-held, battery-powered therapeutic heating device. Operated by the user via a simple non-locking on/off switch, it delivers 50-60°C heat directly to the skin for 20-30 seconds. The device is intended for over-the-counter use to provide temporary relief of pain and itching from insect stings and bites by increasing localized blood flow. The user applies the device to the affected area as long as the heat remains comfortable. Clinical benefits include pain and inflammation relief, as demonstrated by subjective user ratings in clinical trials.

Clinical Evidence

Clinical trials conducted in Venezuela, France, Italy, and Reunion (69 total subjects) evaluated effectiveness for various insect/sea creature stings. Subjects rated pain relief on a 4-point scale: 61/69 reported total disappearance, 7/69 distinct alleviation, 1/69 slight alleviation, 0 ineffective. No serious side effects reported. A 50-subject study on a similar device (Body-Pic) was also referenced as supporting evidence.

Technological Characteristics

Portable, hand-held, battery-powered (9V) heating device. Dimensions: 3cm x 3cm x 10cm; weight: <4 oz. Operates via manual on/off switch. Delivers 50-60°C heat. No software or complex electronics.

Indications for Use

Indicated for temporary relief of pain and itching from insect stings and bites (bees, wasps, mosquitoes) in patients requiring localized blood flow increase.

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.

Predicate Devices

• Health Team Model 501500 Infrared Heater
• Model HT510-500 Infrared Heater
• Model NH-202 Infrared Heat Lamp
• Body Relaxer Infrared Heater and Massager
• Li’s Itch Stopper (K963824)

Reference Devices

• Body-Pic

Submission Summary (Full Text)

{0}

Thermolabile Technologies Corp.
K964397/Amendment 2
August 19, 1997
Therapik®
NOV - 4 1997
K964397

# 510(k) Summary

Pursuant to 512(i)(3)(A) of the Food, Drug and Cosmetic Act, Thermolabile Technologies Corp. is required to submit with this Premarket Notification either an "...adequate summary of any information respecting safety and effectiveness or state that information will be made available upon request of any person." TTC chooses to submit a summary of the safety and effectiveness information. The summary is as follows:

**Trade Name:** Therapik®

**Owner/Operator:** Thermolabile Technologies Corp.
5407 Eglinton Avenue West, Suite 200
Etobicoke, Ontario, Canada M9C 5K6

**Manufacturing Site:** Not yet determined

**Device Generic Name:** Therapeutic heating device

**Classification:** According to Section 513 of the Federal Food, Drug, and Cosmetic Act, the device classification is Class II, Performance Standards (CFR 890.5500).

**Predicate Devices:**

**Health Team Model 501500 Infrared Heater (Manufacturer unknown)**

Model HT510-500 Infrared Heater
Distributed by:
Graham Field, Inc.
400 Rabro Drive, East
Hauppauge, NY 11788

Model NH-202 Infrared Heat Lamp
Distributed by:
National Health Care Equipment Inc.
144 East Kingsbridge Road
Mount Vernon, NY 10550

**Body Relaxer Infrared Heater and Massager (Manufacturer unknown)**
Distributed through the adaptAbility catalog (800-266-8856)

**Li’s Itch Stopper**
Hontech Foundation for Medical Technology
402 Rindge Avenue, 17H
Cambridge, MA 02140
K963824

28

{1}

Thermolabile Technologies Corp.
K964397/Amendment 2
August 19, 1997
Therapik®

## Product Description:

The Therapik is a small, portable, hand-held, battery-powered device equipped with a carrying wrist strap. It measures approximately 3cm x 3cm x 10cm and weighs less than 4 ounces, including the 9 volt battery. The heat is initiated by use of a simple, non-locking, finger-or thumb-activated on/off switch. Heat is produced by pressing the switch. The Therapik device delivers 50 - 60°C heat directly on the user's skin. The user is instructed to apply the device for as long as the heat is comfortable on the skin (approximately 20 - 30 seconds).

## Indications for Use:

The proposed Therapik device will be indicated for the temporary relief of the pain and itching resulting from insect stings and bites such as bees, wasps and mosquitoes by increasing localized blood flow.

## Safety and Performance:

Comparative performance testing was performed on the proposed Therapik device and the predicate National Health Care NH-202 device to establish the comparability of the operating Time/Temperature Profile and the Maximum Operating Temperature of the two devices. The operating characteristics, recommended use time, operating temperature and labeling of the proposed Therapik were also compared to corresponding characteristics of the currently marketed Li's Itch Stopper.

Clinical safety and effectiveness data from clinical trials on the Therapik device conducted in Venezuela (35 subjects) and France, Italy and Reunion (34 subjects) was presented. The 69 total users applied the Therapik to a variety of stings and bites from venomous and non-venomous insects and sea creatures such as bees, wasps, hornets, ants, fleas, ticks, nettles, weaver fish, scorpion fish and jellyfish. Each user was asked to rate the effectiveness of the device in relieving pain and inflammation from the injuries using a subjective rating of 1 (total/complete disappearance of the pain), 2 (distinct alleviation of pain), 3 (slight alleviation of pain) or 4 (not effective). Device ratings were as follows:

Total/complete disappearance of pain = 61/69 users
Distinct alleviation of pain = 7/69 users
Slight alleviation of pain = 1/69 users
Not effective = none

No serious side effects related to the use of the Therapik were reported.

A fifty-subject study on a similar device (Body-Pic) marketed in Canada was also referenced; here, fifty users reported the device to be effective when used to treat the stings and bites of bees, horseflies, wasps, ticks, hornets, sand fleas, ants, and Brulots (mosquitoes).

(Note: Although the clinical data included a variety of insect and sea creature injuries, Therapik is not indicated at this time for the treatment of stings/bites of animals and insects other than bees and wasps).

## Conclusion:

Based on the indications for use, technological characteristics, and clinical testing, the Therapik device has been shown to be safe and effective for its intended use.

{2}

DEPARTMENT OF HEALTH &amp; HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

Ms. Pamela Papineau
Delphi Medical Device Consulting
Representing Thermolabile Technologies Corporation
50 Brewster Street
Pawtucket, Rhode Island 02860

NoV - 4 1997

Re: K964397
Trade Name: Therapik®
Regulatory Class: II
Product Code: ILY
Dated: August 19, 1997
Received: August 21, 1997

Dear Ms. Papineau:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

{3}

Page 2 - Ms. Pamela Papineau

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for *in vitro* diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,


Celia M. Witten, Ph.D., M.D.
Director
Division of General and Restorative Devices
Office of Device Evaluation
Center for Devices and Radiological Health

Enclosure

{4}

Thermolabile Technologies Corp.
K964397/Amendment 2
August 19, 1997
Therapik®

Page 1 of 1

510(k) Number (if known): K964397/A2

Device Name: Therapik®

Indications for Use:

The Therapik is indicated for use to provide temporary relief of the pain and itching resulting from insect stings and bites such as bees, wasps and mosquitoes by increasing localized blood flow.

(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 Devices
510(k) Number K964397

Prescription Use ☐
(Per 21 CFR 801.109)

OR

Over-the-Counter Use ☑

31