HEALTH O METER ELECTRIC HEATING PADS MODELS EHP2, EHP3

K962195 · Sunbeam Health Division · IRT · Nov 27, 1996 · Physical Medicine

Device Facts

• Record ID: K962195
• Device Name: HEALTH O METER ELECTRIC HEATING PADS MODELS EHP2, EHP3
• Applicant: Sunbeam Health Division
• Product Code: IRT · Physical Medicine
• Decision Date: Nov 27, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5740
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Use wherever hot applications 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 pads (Models EHP2, EHP3) provide localized heat therapy; 11.5" x 14.5" dimensions; operate on 110-120V household current. Includes removable covers and sponge inserts for moist heat. Used in home settings by consumers for minor muscular or joint pain relief. Device functions via electrical resistance heating; provides therapeutic heat to target areas as directed by healthcare professionals or for personal comfort.

Clinical Evidence

Bench testing only; device conforms to ANSI/UL Standard #130 for Electric Heating Pads.

Technological Characteristics

Dimensions 11.5" x 14.5"; 110-120V AC power source; resistive heating element; conforms to ANSI/UL Standard #130; includes removable covers and sponge inserts for moist heat.

Indications for Use

Indicated for individuals seeking relief from minor muscular or joint pain where hot applications are 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
K962195
NOV 27 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 Pads, Models EHP2, EHP3
Classification: Class II

Description: Electric Heating Pad, 11.5" x 14.5" conforming to ANSI / UL Standard #130, Electric Heating Pads, operating on standard 110-120V household current. 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 hot applications 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 Models EHP2 and EHP3 are 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: the power source, manufacturing technology, operating principles, intended uses and safety standards are the same for all models. Differences are primarily cosmetic.

Revised September 4, 1996.

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