BMLS03-3

K033174 · Biomedical Life Systems, Inc. · IPF · Jun 30, 2004 · Physical Medicine

Device Facts

• Record ID: K033174
• Device Name: BMLS03-3
• Applicant: Biomedical Life Systems, Inc.
• Product Code: IPF · Physical Medicine
• Decision Date: Jun 30, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

External electrical neuromuscular stimulation using biphasic output is indicated as therapeutic adjunct for: prevention or retardation of muscle disuse atrophy; relaxation of muscle spasm; muscle reeducation; maintaining and increasing the range of motion; increasing local blood circulation and as immediate postsurgical stimulation of calf muscles to prevent venous thrombosis.

Device Story

BMLS03-3 is a portable, battery-powered, four-channel neuromuscular stimulator. Device delivers symmetrical or asymmetrical biphasic rectangular waveforms to muscles via electrodes. Pulse rate 1-120 Hz; pulse width 50-400 microseconds; intensity 0-100 milliamps. Operates in constant, cycled, or reciprocating modes with preprogrammed settings. User interface includes graphic LCD for status and function display. Used by clinicians or patients to provide therapeutic electrical stimulation for muscle rehabilitation and circulation support. Output intensity and pulse parameters are adjusted to achieve desired muscle contraction or relaxation, aiding in atrophy prevention and postsurgical recovery.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Portable, battery-powered, four-channel neuromuscular stimulator. Output: symmetrical or asymmetrical biphasic rectangular waveforms. Pulse rate: 1-120 Hz; pulse width: 50-400 microseconds; intensity: 0-100 mA. Graphic LCD interface. Modes: constant, cycled, reciprocating, and preprogrammed.

Indications for Use

Indicated for patients requiring muscle reeducation, prevention/retardation of disuse atrophy, muscle spasm relaxation, range of motion maintenance, increased local blood circulation, or immediate postsurgical calf muscle stimulation to prevent venous thrombosis.

Regulatory Classification

Identification

A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.

Predicate Devices

• BMLS02-5 Neuromuscular Stimulator (K033174)
• BMLS03-1 Neuromuscular Stimulator (K033174)

Submission Summary (Full Text)

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K033i74

# JUN 3 0 2004

### 510(k) SUMMARY (As required by 21 CFR 807.93)

#### (1) GENERAL

Submitter Name: Address:

| Phone: |
|----------------|
| Fax: |
| Contact: |
| Date Prepared: |

BioMedical Life Systems, Inc. P.O. Box 1360 Vista, CA 92085 760-727-5600 760-727-4220 Richard Saxon 26 September 2003

(2) DEVICE

Name: Trade or Proprietary Name: Common or Usual Name: Classification Name:

BMLS03-3 Neuromuscular Stimulator 21 CFR 890.5850 Powered Muscle Stimulator, Class II IPF

Product Code:

(3) PREDICATE DEVICES

Trade or Proprietary Name: Common or Usual Name: Classification Name:

Product Code:

Trade or Proprietary Name: Common or Usual Name: Classification Name:

BMLS02-5 Neuromuscular Stimulator 21 CFR 890 5850 Powered Muscle Stimulator, Class II IPF

BMLS03-1 Neuromuscular Stimulator 21 CFR 890.5850 Powered Muscle Stimulator, Class II IPF

Product Code:

#### (4) DEVICE DESCRIPTION

The BMLS03-3 is a portable, battery-powered four channel neuromuscular stimulator. The output waveform can be set to symmetrical or asymmetrical biphasic rectangular. The pulse rate range is 1-120 Hz. The pulse width range is 50-400 microseconds. The output intensity range is 0-100 milliamps. It can be set to constant, cycled, or reciprocating modes, and has several preprogrammed modes. All device functions and status are displayed on a graphic LCD.

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## (5) INTENDED USE

The BMLS03-3 is recommended for use for the following conditions:

- Prevention or retardation of muscle disuse atrophy; .
- Relaxation of muscle spasm; .
- Muscle reeducation; ●
- Maintaining and increasing the range of motion; .
- Increasing local blood circulation .
- Immediate postsurgical stimulation of calf muscles to prevent . venous thrombosis.

## (6) COMPARISON TO PREDICATE DEVICE

| Non-clinical Testing: | The BMLS03-3 is identical to the predicate (BioMedical Life Systems, Inc.) BMLS02-5 device in every way except for output pulse strength. The output pulse strength of the BMLS03-3 is equivalent to the predicate (BioMedical Life Systems, Inc.) BMLS03-1. This equivalency was determined through bench testing. |
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Clinical Testing:

Not applicable.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 3 0 2004

Mr. Gary Busset BioMedical Life Systems, Inc. P.O. Box 1360 Vista, California 92085-1360

Re: K033174

Trade/Device Name: Model BMLS03-3 Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: II Product Code: IPF Dated: June 4, 2004 Received: June 7, 2004

Dear Mr. Busset:

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 - Mr. Gary Busset

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 yours,

uriam C. Provost

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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Indications For Use

| 510(k) Number (if known): | K033174 |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | (EMS) Electrical Neuromuscular Stimulator<br>For Muscle Reeducation - Class II<br>Model BMLS03-3 |
| Indications for Use: | External electrical neuromuscular stimulation using biphasic output is<br>indicated as therapeutic adjunct for: prevention or retardation of muscle<br>disuse atrophy; relaxation of muscle spasm; muscle reeducation;<br>maintaining and increasing the range of motion; increasing local blood<br>circulation and as immediate postsurgical stimulation of calf muscles to<br>prevent venous thrombosis. |

Prescription Use *X*
(Part 21 CFR 801, Subpart D)

AND/OR

Over-The-Counter Use (21CFR807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost

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

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