HEALTH O METER ELECTRIC HEATING PAD W/MASSAGE MODEL EHP4

K962252 · Sunbeam Health Division · IRT · Nov 25, 1996 · Physical Medicine

Device Facts

• Record ID: K962252
• Device Name: HEALTH O METER ELECTRIC HEATING PAD W/MASSAGE MODEL EHP4
• Applicant: Sunbeam Health Division
• Product Code: IRT · Physical Medicine
• Decision Date: Nov 25, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5740
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Use wherever applications of heat, massage, or both are desirable for personal comfort, and wherever recommended by your physician, dentist or health care professional for the relief of minor muscular or joint pain.

Device Story

Electric heating pad with massage function; 11.5" x 14.5" dimensions; operates on DC 9V current via standard adapter; includes removable covers and sponge inserts for moist heat. Used in home/consumer settings for personal comfort or pain relief as directed by healthcare providers. Device provides thermal therapy and mechanical massage; output is heat and vibration; healthcare providers use output to manage minor musculoskeletal discomfort; patient benefits from localized pain relief.

Clinical Evidence

Bench testing only; device conforms to ANSI/UL Standard #130.

Technological Characteristics

Dimensions 11.5" x 14.5"; DC 9V power source; includes sponge inserts for moist heat; conforms to ANSI/UL Standard #130.

Indications for Use

Indicated for individuals seeking relief from minor muscular or joint pain as recommended by a healthcare professional or for personal comfort.

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

• Conair Moist Heat Pad (K924799)
• Conair Moist Heat Pad with Automatic Shut-off (K924800)
• Sunbeam / Walgreens Heating Pad (none)

Submission Summary (Full Text)

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Health o meter

510(k) Summary
K962252
NOV 25 1996

Submission Date: September 5, 1996

Contact: Frank Brichetto
Sr. Product Manager
[phone] x 401 - tel.
[phone] - fax

Classification Name: Powered Heating Pad (21 CFR, 890.5740)
Common/Usual Name: Electric Heating Pads
Proprietary Name: Health o meter Electric Heating Pad with massage, Model EHP4
Classification: Class II

Description: Electric Heating Pad, 11.5" x 14.5" conforming to ANSI / UL Standard #130, Electric Heating Pads, operating on DC 9V current supplied through a standard adapter. The units are supplied with removable covers and sponge inserts for moist heat applications, with instructions, in conventional 4-color printed boxes, and are marketed through consumer retail channels.

Intended Use: Use wherever applications of heat, massage, or both are desirable for personal comfort, and wherever recommended by your physician, dentist or health care professional for the relief of minor muscular or joint pain.

Substantial Equivalence Claim: The Model EHP4 is substantially equivalent to the following models which are currently in distribution:
1. Conair Moist Heat Pad, K924799
2. Conair Moist Heat Pad with Automatic Shut-off, K924800
3. Sunbeam / Walgreens Heating Pad none

Substantial equivalence is claimed because: manufacturing technology, operating principles, intended uses and safety standards are the same for all models. Functional differences, i.e. massage action, do not adversely affect safety or efficacy. Other differences are cosmetic in nature.

Revised September 4, 1996

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