SMARTWAVE MS 2000

K041063 · Newwave Medical, LLC · IPF · Dec 1, 2004 · Physical Medicine

Device Facts

• Record ID: K041063
• Device Name: SMARTWAVE MS 2000
• Applicant: Newwave Medical, LLC
• Product Code: IPF · Physical Medicine
• Decision Date: Dec 1, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Prevention of retardation of disuse Atrophy. Increasing local blood circulation. Muscle re-education. Immediate post surgical stimulation of calf muscles to prevent venous thrombosis. Maintaining or increasing range of Motion.

Device Story

Smartwave MS 2000 is a powered muscle stimulator (NMES) generating square waves to stimulate neuromuscular tissues via cutaneous electrodes. Device operates as a 9V battery-powered or AC-adapter-powered unit. It features 1 or 2 output channels with pulsed DC, AC, and Russian Stim modes. User interface includes an LCD for intensity levels (0-35) and low battery status. Device includes a timer (0-60 min) and automatic shut-off after 10 minutes of inactivity. Used in clinical or home settings to treat muscle spasms, atrophy, and circulation issues. Healthcare providers or patients apply electrodes to target muscles; output intensity is manually controlled. Benefits include improved muscle function, circulation, and prevention of venous thrombosis post-surgery.

Clinical Evidence

No clinical data. Substantial equivalence is based on technological characteristics and bench testing comparisons of electrical output, leakage current, and safety features.

Technological Characteristics

Powered muscle stimulator; 9V battery or 100-120VAC adapter; ABS plastic housing; independent isolation transformer; constant current output (+5%); LCD interface; dimensions 4.68" x 2.77" x 1.01"; weight 6.24 oz. Complies with UL544 safety standards.

Indications for Use

Indicated for relaxation of muscle spasms, prevention/retardation of disuse atrophy, increasing local blood circulation, muscle re-education, immediate post-surgical stimulation of calf muscles to prevent venous thrombosis, and maintaining/increasing range of motion.

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

• Staodyn EMS +2 (K926510)

Submission Summary (Full Text)

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K04/063

neuromuscular tissues through cutaneous electrodes connected by

lead wires to the generator.

Relaxation of muscle spasms.

DEC

| C - 1 2004 | |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Attachment A |
| | 510(k) Summary of Safety and Effectiveness |
| Date Prepared: | April 19, 2004 |
| Submitter: | Newwave Medical, LLC |
| | 620 Haggard ST. STE 614<br>Plano, TX 75074<br>[phone] |
| Contact Person: | Robert Armstrong |
| Trade (Proprietary) Name: | Smartwave MS 2000 |
| Common/Classification Name: | Powered Muscle Stimulator |
| Device Classification: | Class II |
| Predicate Device: | Staodyn, Inc. |
| Description of Device: | The Smartwave MS 2000 Muscle<br>Stimulator is a Square wave<br>generator designed for<br>neuromuscular electrical stimulation<br>(NMES). The MS 2000 stimulates |

## Statement of Intended Use:

## Prevention of retardation of disuse Atrophy. Increasing local blood circulation. Muscle re-education. Immediate post surgical stimulation of calf muscles to prevent venous thrombosis. Maintaining or increasing range of Motion. Technological Characteristics: The new device has the same Technological characteristics as the Predicate device. See table 1 (next Page) for a summary of the Technological characteristics of the New device in comparison to those of The predicate device.

A 2

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| Comparison of the Smartwave MS 2000 and Staodyn EMS +2 | | |
|--------------------------------------------------------|---------------------------------------------------------------------------------------------------------|---------------------------------------|
| | New Device | Marketed Device |
| 1) 510 (k) Number | This Submission | K926510 |
| 2) Device Name | Smartwave MS 2000 | EMS +2 |
| 3) Manufacturer | Newwave Medical, LLC | Staodyn Inc. |
| 4) Power Source | 9V | 9V |
| Optional wall adapter | 100-120vac, 50-60Hz | no |
| Method of line current<br>Isolation | Transformer coupled | |
| Patient leakage current<br>(w/adapter) | | |
| Normal condition | 3.2uA | |
| Single fault | 6.5uA | |
| 5) # of output modes | Pulsed DC, AC, Russian Stim | Pulsed DC, AC |
| 6) # of output channels | 1 or 2 | 1 or 2 |
| Synchronous | yes | yes |
| Reciprocal | no | no |
| 7) Computerized | no | no |
| 8) Software Provided | no | no |
| 9) Constant Current (+5%) | yes | yes |
| 10) Constant Voltage | no | no |
| 11) Max Output Current<br>each channel | 57.2mA-500~<br>17.8mA-2K~ | 95.2mA-500~<br>46.8mA-2K~ |
| (+5%) | 3.8mA-10K~ | 9.63mA-10K~ |
| 12) Max Output Voltage<br>baseline-to-peak | 28.6V-500~<br>35.5V-2K~<br>38.3V-10K~ | 47.6V-500~<br>93.6V-2K~<br>96.3V-10K~ |
| 13) Channel isolation | Independent isolation transformer | Capacitor coupled |
| 14) Line Current isolation | Transformer coupled | N/A |
| 15) Automatic overload trip | no | no |
| 16) Automatic no load trip | yes<br>(when the unit is turned on, if<br>it is not used, it will turn itself off<br>after 10 minutes.) | no |
| 17) Patient override control | yes (by turning off unit) | yes (by turning off unit) |
| 18) Max leakage current (uA)<br>chassis (input) | N/A | N/A |
| electrodes (output) | N/A | N/A |
| 19) Indicator display | LCD | no |
| unit functioning | yes | yes (red LEDs) |
| low battery indicator | yes (Lo b displayed @ <6.0V) | yes (yellow LED on @ <6.0V) |
| intensity level<br>20) UL544 | yes (0 to 35 displayed)<br>(complies with UL544 Safety<br>Standard for Medical Equip.) | rotary dials |
| 21) Timer Settings (range) (+1%) | 0-60 min., 0 is constant on | 15, 30, 60 min. and constant on |
| 22) Automatic shut off | yes | yes |
| 23) Weight | 6.24 oz. | 9.8 oz. |
| 24) Dimensions (in.) | 4.68L x 2.77W x 1.01H | 5.4L x 3.2W x 1.15H |
| 25) Housing materials and<br>construction | ABS plastic injection molded | ABS plastic vacuum molded |

## Attachment A Table 1 Comparison of the Smartwave MS 2000 and Staodyn EMS +2

:

: 2

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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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure with three wavy lines emanating from it.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 1 2004

Mr. Robert Armstrong President Newwave Medical, LLC 620 Haggard Street, Suite 614 Plano, Texas 75074

Re: K041063

Trade/Device Name: Smartwave MS 2000 Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: II Product Code: IPF Dated: October 29, 2004 Received: October 29, 2004

Dear Mr. Armstrong:

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 mav 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. Robert Armstrong

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.

Sincerely yours,

Murle A. Mellersen
for

Colie M. Witte, Ph.D., M.P.

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): 长۵4106 3 Device Name: Smart USA & M \$ 2000 Indications For Use:

- 1. Relaxation of muscle spasms
- 2. Prevention or retardation of disuse atrophy
- 3. Increasing local blood circulation
- 4. Muscle re-education
- ર. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
- 6. Maintaining or increasing range of motion

Prescription Use
(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 (ODE)

R. Mark A. Mulkersen

Division Sion-Division of General, Restorative, and Neurological Devices

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510(k) Number K041063