MANTRA COMBO, MODEL MECS 320

K091236 · Mantra Intl. (Hk) , Ltd. · GZJ · Jul 30, 2009 · Neurology

Device Facts

• Record ID: K091236
• Device Name: MANTRA COMBO, MODEL MECS 320
• Applicant: Mantra Intl. (Hk) , Ltd.
• Product Code: GZJ · Neurology
• Decision Date: Jul 30, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

a. TENS: The device is intended for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of post-surgical and post traumatic acute pair. b. NMS: The device in recommended for use for the following conditions: 1. Relaxation of muscle spasms 2. Prevention of retardation of disuse atrophy 3. Increasing local blood circulation 4. Muscle re-education 5. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis 6. Maintaining and increasing range of motion.

Device Story

Battery-powered, dual-channel transcutaneous nerve stimulator (TENS) and neuromuscular stimulator (NMS); housed in small, lightweight cabinet. Device delivers electrical stimulation via lead wires to patient skin. User selects between TENS or NMS modalities; circuitry and programs identical to predicate devices. Used in clinical or home settings; operated by patient or clinician. Output provides electrical pulses to nerves for pain management or muscles for therapeutic stimulation (spasm relief, atrophy prevention, circulation, re-education, range of motion).

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Battery-powered, dual-channel electrical stimulator. Materials include standard cabinet and lead wires. Operates as both TENS and NMS. No software algorithm details provided; device uses fixed circuitry/programs identical to predicates.

Indications for Use

Indicated for patients requiring symptomatic relief of chronic intractable pain, management of post-surgical/post-traumatic acute pain, relaxation of muscle spasms, prevention/retardation of disuse atrophy, increased local blood circulation, muscle re-education, prevention of venous thrombosis via calf stimulation, and maintenance/increase of range of motion.

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

• Mantra TENS Model NT3 (K041520)
• Classic NMS (K021905)

Submission Summary (Full Text)

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091236

Page. 1/2

SECTION 5.0

Mantra International (HK) Ltd 1504 Vigor Industrial Building, Block B, 20 Cheung Tat Road Tsing Yi Hong Kong Tel: [phone]

JUL 3 0 2009

## 510(k) Summary

1. General Information

Trade Name of Device:

### "Mantra Combo"

Common/Usual Name:

Classification Name:

Submitters Name and Address:

Manufacturer:

Transcutaneous Nerve Stimulator combined with Neuromuscular Stimulator

Stimulator, Nerve, Transcutaneous for Pain Relief, Combined with Powered Muscle Stimulator

Mantra International (HK) Ltd. 1504 Vigor Industrial bldg Block B, 14-20 Cheung Tat Road Tsing Yi, Hong Kong, China

Mantra International (HK) Ltd. 1504 Vigor Industrial bldg Block B, 14-20 Cheung Tat Road Tsing Yi, Hong Kong, China Registration Number: 3003741750

### Device Description

2.

3.

The "Mantra Combo" combined TENS and NMS dual channel device is housed in small lightweight cabinet and is battery powered. The same circuitry is used to for both TENS and NMS.

### Indications for Use

a. TENS: The device is intended for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of post-surgical and post traumatic acute pair.

b. NMS: The device in recommended for use for the following conditions:

1. Relaxation of muscle spasms

2. Prevention of retardation of disuse atrophy

3. Increasing local blood circulation

4. Muscle re-education

5. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis

6. Maintaining and increasing range of motion.

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Lo91236. Page 2/2

## Substantial Equivalence

This product is substantialiy equivalent to the Mantra TENS Model NT3 (K041520) Combined with the Classic NMS™ manufactured by Care Rehab Inc of McLean Virginia (K021905). The device is physically identical to both the Manta TENS NT3 and Classic NMS™ consisting of exactly the same cabinet, PCB and circuity. The TENS functionality (Modes and programs) of the Mantra COMBO is identicy.
the Mantra NT3 TENS and the NMS function in the Mantra COMBO is identical the Mantra NT3 TENS and the NMS functionality (modes and programs) is identical
the Mantra NT3 TENS and the NMS finctionality (modes and programs) is identical that of the Classic NMS™. Since the Classic NMS™ is also produced by Mantra International Ltd, all the technical characteristics, (including lead wires) are identical. The user can select either TENS or NMS modalities. In this way it is simply "two products in one".

# Performance Studies

Performance testing was conducted on the "Mantra Combo" combined TENS & NMS device to demonstrate the integrity, suitability and substantial equivalence of the device

#### 6. Conclusion

ડી.

Based upon the Indications for use and performance studies the "Mantra Combo" has been shown to be substantially equivalent for its intended use.

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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# JUL 3 0 2009

Mantra International, Ltd. c/o Mr. Brent Reider President, International Trade Group, Inc. 4663 Kate Lane Oxford. OH 45056

Re: K091236

Trade/Device Name: Mantra Combo Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator for Pain Relief Regulatory Class: II Product Code: GZJ Dated: July 2, 2009 Received: July 7, 2009

Dear Mr. Reider:

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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/cdrl/industry/support/index.html.

Sincerely yours,

Joe Callaway for

Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known):

k011236

Device Name: Mantra Combo (Combined TENS & NMS device)

# Indications For Use:

a. TENS: The device is intended for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of postsurgical and post traumatic acute nain surgical and post traumatic acutes an a

b. NMS: The device is recommended for use for the following conditions:
1. Relaxation of muscle spasms

1. Relaxation of muscle spasms

2. Prevention of retardation of disuse atrophy

3. Increasing local blood circulation

4. Muscle re-education

5. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
6. Maintaining and increasing range of motion

6. Maintaining and increasing range of motion.

iption Use _ AND/OR Over-The-Counter Use R 801 Subpart D)

(21 CFR 807 Subpart C)

EASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER

07/20/09

ivision Sten of vision of Ophthalmic, Neurological and Ear, and Throat Devi

510(k) Number k091236

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