ELASTOPLAST HEAT PLASTER

K925630 · Beiersdorf, Inc. · IRT · Feb 25, 1994 · Physical Medicine

Device Facts

• Record ID: K925630
• Device Name: ELASTOPLAST HEAT PLASTER
• Applicant: Beiersdorf, Inc.
• Product Code: IRT · Physical Medicine
• Decision Date: Feb 25, 1994
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5740
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The plaster is to be used for the relief of minor muscular aches.

Device Story

Elastoplast Heat Plaster is a topical back plaster applied to the skin to provide a warming sensation for the relief of minor muscular aches. The device functions via chemical ingredients that generate heat upon application to the skin. It is intended for consumer use. The device is a modification of the previously marketed ABC Heat Plaster, involving the removal of a proprietary ingredient to enhance product safety while maintaining the warming effect.

Clinical Evidence

No clinical data provided; substantial equivalence is based on formulation comparison and safety assessment regarding the removal of a proprietary ingredient.

Technological Characteristics

Topical plaster/adhesive patch form factor. Operates via chemical-based warming mechanism. Non-powered, non-electronic device.

Indications for Use

Indicated for the relief of minor muscular aches in patients requiring topical warming therapy.

Regulatory Classification

Identification

A powered heating pad is an electrical device intended for medical purposes that provides dry heat therapy for body surfaces. It is capable of maintaining an elevated temperature during use.

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E part 807 of this chapter subject to § 890.9.

Predicate Devices

• ABC Heat Plaster
• Hospital Brand Medicated Heavy Back Plaster (The Gansett Company)

Submission Summary (Full Text)

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FDA

U.S. FOOD & DRUG

ADMINISTRATION

November 1, 2021

Beiersdorf, Inc.

Kenneth Nicoll

360 Martin Luther King Dr.

P.O. Box 5529

Norwalk, Connecticut 06856

Re: K925630

Trade/Device Name: Elastoplast Heat Plaster

Regulation Number: 21 CFR 890.5740

Regulation Name: Powered heating pad

Regulatory Class: Class II

Product Code: IRT

Dear Kenneth Nicoll:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated February 25, 1994.

Specifically, FDA is updating this SE Letter because FDA has better categorized your device technology under product code IRT.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Amber Ballard, OHT5: Office of Neurological and Physical Medicine Devices, 240-402-9983, [e-mail].

Sincerely,

Sergio M. De Del Castillo -S

Digitally signed by Sergio M. De Del Castillo -S

Date: 2021.11.01 17:36:13 -04'00'

for Amber Ballard, Ph.D.

Assistant Director for Physical Medicine –

Neurodegenerative Devices Team

DHT5B: Division of Neuromodulation and Physical

Medicine Devices

OHT5: Office of Neurological and Physical Medicine

Devices

Office of Product Evaluation and Quality

Center for Devices and Radiological Health

U.S. Food & Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993

www.fda.gov

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

FEB 25 1994

Food and Drug Administration

1390 Piccard Drive

Rockville MD 20850

Mr. Kenneth M. Nicoll

Supervisor Reg./Leg.

Beiersdorf, Inc.

BDF Plaza

360 Martin Luther King Drive

P.O. Box 5529

Norwalk, Connecticut 06856-5529

Re: K925630

Elastoplast Heat Plaster

Regulatory Class: Unclassified

Dated: October 30, 1992

Received: November 6, 1992

Dear Mr. Nicoll:

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 to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments. You may, therefore, market the device, subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (Act). The general controls provisions of the Act include requirements for registration, listing of devices, good manufacturing practice, and 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. In addition, the Food and Drug Administration (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 the Radiation Control for Health and Safety Act of 1968, or other Federal Laws or Regulations.

This letter immediately will allow you to begin marketing your device as described. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market, but it does not mean that FDA approves your device. Therefore, you may not promote

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Page 2 - Mr. Nicoll

or in any way represent your device or its labeling as being approved by FDA. If you desire specific advice on the labeling for your device, please contact the Office of Compliance, Promotion and Advertising Policy Staff (HFZ-326) at [phone]. Other general information on your responsibilities under the Act, may be obtained from the Division of Small Manufacturers Assistance at their toll free number [phone] or at [phone].

Sincerely yours,

Paul R. Beninger

Paul R. Beninger, M.D.

Director

Division of General and

Restorative Devices

Office of Device Evaluation

Center for Devices and

Radiological Health

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K925630

FEB 25 1994

# 510-k Summary

This summary is submitted pursuant to 21 CFR 807.92.

1. Submitter-
Beiersdorf, Inc.
360 Dr. Martin Luther King Drive
Norwalk, CT 06856
[phone]
Contact Person- Kenneth M. Nicoll
January 19, 1994

2. Device Name- ElastoplastR Heat Plaster
Common Name- Back Plaster

3. The product is substantially similar to our prior product which was known as ABC Heat Plaster. ABC Heat Plaster was found substantially similar to Hospital Brand Medicated Heavy Back Plaster, which was marketed by The Gansett Company, North Grosvenordale, CT.

4. When the plaster is placed on the skin according to instructions it encourages a warming sensation that helps to relieve minor muscular aches to the area it is applied.

5. The plaster is to be used for the relief of minor muscular aches.

6. The primary difference between Elastoplast Heat Plaster and the predicate device is the removal of one ingredient. The identity of the ingredient is considered to be proprietary. The removal of the ingredient promotes the safety of the product. The remaining ingredients encourage a warming of the body area the plaster is used on. Therefore the product is not only safer, but, still effective.

6(b)(1)(2) & (3) - Not applicable