ACULIFE, MODEL SMW-01

K051197 · Inno-Health Technology, Inc. · BWK · Mar 28, 2006 · NE

Device Facts

• Record ID: K051197
• Device Name: ACULIFE, MODEL SMW-01
• Applicant: Inno-Health Technology, Inc.
• Product Code: BWK · NE
• Decision Date: Mar 28, 2006
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

The intended use of ACULIFE/Model SMW-01 is an ELECTRO-ACUPUNCTURE DEVICE for use in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states. ACULIFE/model SMW-01 is intended for the stimulation at hands of patient.

Device Story

ACULIFE/Model SMW-01 is a battery-powered portable electro-acupuncture stimulator. Device utilizes 9V/DC battery or 9V adaptor to deliver electrical stimulation via lead wires connected to one probe electrode and one adhesive electrode. Operated by qualified acupuncture practitioners in clinical settings to provide hand stimulation. User adjusts output amplitude and operation time; device includes memory for amplitude settings. Output affects patient through localized electrical stimulation, intended to support acupuncture practice.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included electrical safety (EN 60601-1, EN 60601-1-1), electromagnetic compatibility (EN 60601-1-2), biocompatibility (ISO 10993), skin impedance loading, and output characteristic verification.

Technological Characteristics

Portable electro-acupuncture stimulator; 9V/DC battery or 9V adaptor power source. Includes probe and adhesive electrodes with lead wires. Features adjustable output amplitude, amplitude memory, and timer. Biocompatibility per ISO 10993; electrical safety per EN 60601-1; EMC per EN 60601-1-2.

Indications for Use

Indicated for patients requiring electro-acupuncture stimulation at the hands, administered by qualified acupuncture practitioners.

Predicate Devices

• S.H.P International / model ACUSTIM (K014237)

Submission Summary (Full Text)

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K051197

## 510(k) SUMMARY

| submitters Information: | Inno-Health Technology, Inc.<br>8F-2, No.61, Kung Yi Road Sec. 2,<br>Taichung, Taiwan 408, Republic of China |
|-------------------------|--------------------------------------------------------------------------------------------------------------|
|-------------------------|--------------------------------------------------------------------------------------------------------------|

- Terry C. Chiang Contact Person: Tel: [phone]
Date Summary Prepared. March 30, 2005

Device Information:

| Classification name: | Electro-Acupuncture. |
|----------------------|-----------------------|
| Common / Usual name: | ACULIFE/Model SMW-01. |
| Classification: | Class II. |
| Regulatory Class: | Unclassified. |
| Product Code: | BWK. |

Substantial equivalence: S.H.P International / model ACUSTIM (510k number: k014237)

Description of the Device:

The device consists of a battery powered portable instrument, with a basic power pack which is connected by conducting lead wire to two electrodes (one probe electrode and one big adhesive electrode) which make contact for hands stimulation.

## Indications For Use:

The intended use of ACULIFE/Model SMW-01 is an ELECTRO-ACUPUNCTURE DEVICE for use in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.

ACULIFE/model SMW-01 is intended for the stimulation at hands of patient.

Technological Characteristics:

ACULIFE uses a 9V/DC battery or 9V adaptor as the supply power of the stimulation unit. It can be adjusted for the output amplitude, keep the memory of chosen amplitude, and set the operation time. The electrode combination and lead wire provide the electro-acupuncture stimulation for hand by or on the order of a qualified practitioner of acupuncture as determined by the states.

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Performance Data:

- EN 60601-1 & EN 60601-1-1 for Electric Safety. -
- EN 60601-1-2 for EMC. "
- ISO 10993 for biocompatibility. -
- Skin impedance test for the estimation of loading -
- Output Characteristics testing for product specification.

Statement of indication for use : See the following page.

Conclusion : Based on the documents provided in the 510(K) submission, the Inno-Health electrode acupuncture, model ACULIFE/ SMW-01 is substantial equivalent the chosen FDA cleared model : S.H.P International / model ACUSTIM.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 8 2006

Mr. Terry Chiang President Inno-Health Technology, Inc. 8F-2, No. 61, Kung Yi Road Section 2 Taichung, Taiwan 408 Republic of China

Re: K051197

Trade/Device Name: ACULIFE Model SMW-01 Regulation Name: Electro-Acupuncture Stimulator Regulatory Class: Unclassified Product Code: BWK Dated: January 12, 2006 Received: January 24, 2006

Dear Mr. Chiang:

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 forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic

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## Page 2- Mr. Terry Chiang

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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,

Hulut Semen

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

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## Indications for use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ K051197 ---

Device Name: Electro-Acupuncture; ACULIFE/Model SMW-01.

Indications For Use:

The intended use of ACULIFE/Model SMW-01 is an ELECTRO-ACUPUNCTURE DEVICE for use in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.

ACULIFE/model SMW-01 is intended for the stimulation at hands of patient.

Prescription Use V (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (Part 21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Helglen
(Division Sign Off)

Division of General, Restorative, and Neurological Devices

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**510(k) Number** Ko 51197