BASBA E-MACHINE

K041172 · Basba, Inc. · GZJ · Nov 18, 2004 · Neurology

Device Facts

• Record ID: K041172
• Device Name: BASBA E-MACHINE
• Applicant: Basba, Inc.
• Product Code: GZJ · Neurology
• Decision Date: Nov 18, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Basba E-Machine is intended for temporary symptomatic relief and management of chronic intractable pain and as an adjunctive treatment in the management of post-surgical and post-traumatic pain.

Device Story

Basba E-Machine is a non-invasive transcutaneous electrical nerve stimulator (TENS) for pain management. Device inputs include power via AC-DC adapter; system features serial RS-232 connection. Unit dimensions approximately 17 cm x 15 cm x 4 cm. Faceplate includes green LED (working status), red LED (power indicator), three output sockets for electrical stimulation, and one ground socket. Device delivers continuous wave duty cycle electrical stimulation via paired electrodes to the patient. Operated by healthcare providers or patients for symptomatic relief of chronic, post-surgical, or post-traumatic pain. Output affects clinical decision-making by providing adjunctive pain management therapy.

Clinical Evidence

Bench testing only. Evidence consists of functional performance testing and electrical safety testing to demonstrate compliance with generally accepted performance specifications for TENS devices.

Technological Characteristics

Non-invasive TENS device; dimensions 17 cm x 15 cm x 4 cm. Sensing/actuation: electrical stimulation via paired electrodes. Energy source: AC-DC adapter. Connectivity: serial RS-232 port. Operation: continuous wave duty cycle. Indicators: LED status lights.

Indications for Use

Indicated for temporary symptomatic relief and management of chronic intractable pain and as an adjunctive treatment for post-surgical and post-traumatic pain in patients requiring TENS therapy.

Regulatory Classification

Identification

A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.

Predicate Devices

• Apex Medical Digital TENS TS1211, TS1212 (K021755)
• Biomedical Life Systems, Inc. Electro-Nerve Stimulator TENS, Model Bmls03-5 (K033455)

Submission Summary (Full Text)

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K041172

Basba E-Machine 510(k) Notification
April 30, 2004.

NOV 1 8 2004

# APPENDIX A

# 510(k) PREMARKET NOTIFICATION SUMMARY

(Per 21 CFR 807.92)

- I. Applicant: Teresa Yang Basba Inc. 15342-B East Valley Blvd. City of Industry CA 91746 626 / 336-9737 telephone 626 / 336-9237 facsimile Email: [e-mail]
- Key Contact: M. Joyce Heinrich Texas Applied Biomedical Services, Inc. 12101 Cullen Blvd., # A Houston, Texas 77047 713 / 734-4433 telephone 713 / 734-5671 facsimile Email: [e-mail]

#### II. Device Name

| Proprietary Name: | Basba E-Machine |
|----------------------|--------------------------------------------|
| Common / Usual Name: | TENS Device |
| Classification Name: | Transcutaneous electrical nerve stimulator |
| Product Code: | GZJ |

### III. Predicate Device

The Basba E-Machine is substantially equivalent to other Transcutaneous Electrical Nerve Stimulator (TENS) devices currently in commercial distribution such as the Apex Medical Corporation's Apex Medical Digital TENS TS1211, TS1212 (K021755) and Biomedical Life Systems, Inc. Electro-Nerve Stimulator TENS, Model Bmls03-5 (K033455).

### IV. Intended Use of the Device

The Basba E-Machine is intended for use as a symptomatic relief and management of chronic and acute pain and as an adjunctive treatment in the management of post-surgical and post-traumatic pain.

### V. Description of the Device

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The Basba E-Machine is a non-invasive, transcutaneous electrical stimulation device, which is intended for use as an adjunctive treatment for individuals suffering from chronic intractable pain. The system consists of a.TENS Unit, AC-DC adapter to power the unit and a serial RS-232 connection cable. The Unit is approximately 17 cm x 15 cm x 4 cm. Two light emitting diodes (LED) are located on the faceplate of the Unit. The green LED indicates the working status of the device and the red LED is the power indicator. There are four sockets located on the faceplate of the Unit: three of them labeled "OUT" provide the output electrical current for 3 different types of connectors and the fourth socket is the ground socket labeled GND.

## Summary of the Technical Characteristics of the Basba E-Machine as VI. Related to the Referenced Predicate Devices.

The Basba E-Machine has comparable technical and performance characteristics as currently marketed TENS devices. The E-Machine and the referenced predicate devices use similar electronic components to provide electrical stimulation via paired electrodes to the subject. All of these devices are operated at continuous wave duty cycles.

### VII. Testing

Testing of the Basba E-Machine includes functional performance testing and electrical safety testing.

## VIII. Conclusions

In comparison to the predicate devices, the Basba E-Machine has the same intended uses and similar technical, functional and performance characteristics. The Basba E-Machine is designed to comply with the generally accepted performance specifications for TENS devices.

The Basba E-Machine performs as intended and does not raise any new safety or efficacy issues.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol resembling an abstract human figure with three flowing lines representing the body and arms.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 8 2004

Basba Inc. C/o Mrs. M. Joyce Heinrich Texas Applied Biomedical Services, Inc. 12101 Cullen Boulevard, #A Houston, Texas 77047

Re: K041172

Trade/Device Name: Basba E-Machine Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: II Product Code: GZJ Dated: November 9, 2004 Received: November 15, 2004

Dear Mrs. M. Joyce Heinrich:

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 (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.

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Page 2 - Mrs. M. Joyce Heinrich

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/dsma/dsmamain.html

Sincerely vours.

R. Mark McMullen

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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KO41172

## APPENDIX B

## Indications for Use

510(k) Number (if known):

Pending

Device Name: Basba E-Machine

## Indications for Use:

The Basba E-Machine is intended for temporary symptomatic relief and management of chronic intractable pain and as an adjunctive treatment in the management of post-surgical and post-traumatic pain.

Prescription Use: X (Part 21 CFR 801 Subpart D)

AND/OR

Over the Counter Use: (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODpE)

Mark A. Millerson

torative, and Netti

K041172

510(k) Number-

000020