THERMASSAGE

K061001 · Thermage, Inc. · GEI · Oct 12, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K061001
• Device Name: THERMASSAGE
• Applicant: Thermage, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Oct 12, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Relief of minor muscle aches and pains. Relief of muscle spasm. Temporary improvement of local circulation (i.e., blood circulation). Temporary improvement in the appearance of cellulite.

Device Story

TherMassager is a 9.0 VDC hand-held, box-like therapeutic massager weighing approximately 4 pounds. Device contains a suction pump, massage motor, and three interchangeable rollers (spiral, ribbed, lobed). Operator secures unit to hand via strap for application. Rollers provide mechanical massage action to skin. Device is intended for relief of minor muscle aches, pains, and spasms, and temporary improvement of local circulation and cellulite appearance. Operation is user-controlled with variable speed settings. Device is powered by an AC/DC adapter.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Housing: medical grade plastic (2401 MT SG). Rollers: medical grade silicone elastomer (ISO 10993 compliant). Power: 9 VDC via AC/DC adapter (120 VAC input). Operation: suction pump, massage motor, and powered rollers. Variable speed control. Leakage current <50 microamps. Vacuum range: 760-400 Torr.

Indications for Use

Indicated for individuals experiencing minor muscle aches, pains, or muscle spasms, and for those seeking temporary improvement in local blood circulation or the appearance of cellulite.

Regulatory Classification

Identification

An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

Predicate Devices

• UPC Therapeutic Massager (K990445)

Submission Summary (Full Text)

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K061001

| Summary of 510(k) Information<br>Premarket Notification, Section 510(k) | | | | THERMAGE, INC.<br>OCTOBER 6, 2006 |
|-------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------|--|-----------------------------------|
| | Regulatory Authority: | Safe Medical Devices Act of 1990, 21 CFR 807.92 | | |
| 1. | Device Name: | | | |
| | Trade Name: | TherMassager | | OCT 12 2006 |
| | Common<br>Name(s): | Therapeutic massager | | |
| | Classification<br>Name(s): | Therapeutic massager | | |
| 2. | Establishment Name & Registration Number: | | | |
| | Name: | Thermage, Inc. | | |
| | Number: | 2954746 | | |
| 3. | Classification(s): | | | |
| | Sec. § 890.5660<br>(a) Identification. A therapeutic massager is an electrically powered device intended for medical<br>purposes, such as to relieve minor muscle aches and pains. | | | |
| | Device Class: | Class I for all requested indications | | |
| | Classification Panel: | Physical Medicine | | |
| | Product Code(s): | ISA | | |

#### Equivalent Predicate Device: 4.

Thermage believes that the TherMassager is substantially equivalent to the massage system identified below:

I. UPC Therapeutic Massager, K990445, LPG, USA, Inc.

### Device Description: 5.

The TherMassager is a self-contained, 9.0 VIDC electrically powered therapeutic massager. The basic configuration is that of an ergonomically rounded hand-held box-like unit. Weight is approximately 4 pounds. The housing is made from medical grade plastic and contains a suction pump, a massage motor and skin rollers. The outside of the unit is affixed with a strap which may be secured over the operators hand to provide additional grip during treatment application. Three treatment rollers are supplied with each unit. The TherMassager unit has I spiral roller, 1 ribbed roller and 1 lobed (contoured) roller. The rollers are made from medical grade silicone elastomer meeting ISO 10993 biocompatibility standards.

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# Table of device characteristics.

| Feature | TherMassager | LPG | SF? |
|----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------|--------|
| Indications for Use | Relief of minor musele aches and pains<br>Relief of musele spasm<br>Temporary improvement of local circulation<br>(i.e., blood circulation)<br>Temporary improvement in the uppearunce of<br>cellulite | SAME | y ES |
| Power Requirements | AC/DC Aduptor<br>Input = 120 VDC - 60 Hz<br>Output = 9 VDC | 120 VAC -- 60 ILz | YES |
| Weight:<br>Massager<br>AC/DC Adapter | 1.8 Kg<br>.5 Kg | 2 Kg - Handpiece only | yes |
| Leakage Current | =50 micump | <50 micamp | YES |
| Vacuum (Torr)<br>760 Torr =<br>I atmosphere) | Variable, 760-400 Tim | Variable, 50-500 mBar<br>720 - 385 Torr equivlacut | પ્રદેશ |
| Materials | Housing: medical grade plastic - 2401 MT SG<br>Rollers siliconc - ISO 10993 compliant | Medical grade materials<br>unspecified | YES |
| Massage Unit | Variable speed - User controlled | Variable according to vacuum freq.<br>and cycle rate | YES |
| Vacuum frequency &<br>evele rate | Constant - force variable | Variable - pulsatos | YES |
| Rollers | Powered | Powered | ਮ ਜੋੜ |

## Summary basis for equivalence.

Based on a direct comparison of the information and attributes summarized in the table above, Thermage believes that the TherMassager is substantially equivalent to the referenced massage system. Equivalence can be seen in the design, material composition, mode of action and intended use.

# Indications for Use.

- Relief of minor muscle aches and pains .
- * Relief of muscle spasm
- Temporary improvement of local circulation (i.e., blood circulation) .
- . Temporary improvement in the appearance of cellulite

#### Applicant Name & Address: રું.

Thermage, Inc. 25881 Industrial Blvd Hayward, CA 94545-2991 510.782.2286 fax [phone]

### 7. Company Contact:

Ms. Pamela M. Buckman, RN, MS Thermage, Inc. 25881 Industrial Blvd Hayward, CA 94545-2991 510.782.2286 fax [phone]

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol. The logo is simple and recognizable, and it is used to represent the U.S. Department of Health & Human Services.

NOV 18 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Thermage, Inc. % Ms. Sharon Thompson, VP RA/QA 25881 Industrial Boulevard Hayward, California 94545-2991

Re: K061001

Trade/Device Name: Thermage TherMassager Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: September 08, 2006 Received: September 11, 2006

Dear Ms. Thompson:

This letter corrects our substantially equivalent letter of October 12, 2006.

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

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Page 2 - Ms. Sharon Thompson

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.

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Neil RP Ogden

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

Enclosure

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Page I of I

510(k) Number:

Device Name(s): TherMassager

kobioci

Indications for Use:

The TherMassager is indicated for use in:

- Relief of minor muscle aches and pains 비
- 요 Relief of muscle spasm
- Temporary improvement of local circulation "(i.e., "blood" circulation)" 이
- Temporary improvement in the appearance of cellulite 트

| Prescription Use | X |
|------------------|----------------------|
| OR | Over-The-Counter Use |

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil R. Goldman

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

**510(k) Number** K061001

(Per 21 CFR 801.109)

(Optional format 1-2-96)