ENDOR 2000

K984376 · T.C. Medical, Inc. · GZJ · Jun 7, 2000 · Neurology

Device Facts

• Record ID: K984376
• Device Name: ENDOR 2000
• Applicant: T.C. Medical, Inc.
• Product Code: GZJ · Neurology
• Decision Date: Jun 7, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Symptomatic relief and management of chronic (long-term) intractable pain and as an adjunctive treatment in the management of post surgical and post traumatic acute pain problems.

Device Story

EnDor 2000 is a Transcutaneous Electrical Nerve Stimulation (TENS) device. It delivers electrical impulses to manage pain. Device operates by mimicking electrical parameters and circuitry of predicate model 804S III. Intended for symptomatic relief of chronic intractable pain and adjunctive management of post-surgical or post-traumatic acute pain. Operated by healthcare providers or patients under prescription. Output consists of electrical stimulation to the patient. Clinical benefit is pain management.

Clinical Evidence

No clinical data. Bench testing only comparing electrical specifications to the predicate device.

Technological Characteristics

TENS device; electrical stimulation via circuitry mimicking predicate model 804S III. Electrical parameters and circuitry are the primary technical characteristics.

Indications for Use

Indicated for patients requiring symptomatic relief and management of chronic intractable pain, or as adjunctive treatment for post-surgical and post-traumatic acute pain.

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

• model 804S III (K893874B)

Submission Summary (Full Text)

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510K Summary: Non clinical data submitted (Basic Design Description of submission) compares the specifications of the ENDOR 2000 with a legally marketed product, the model 804S III (K893874B) sold by Altoona Medical Supply and manufactured by the manufacturer of the ENDOR 2000.

Because the electrical parameters mimic those of the 804S III, it is claimed that the ENDOR 2000 is substantially equivalent to an existing, legally marketed product.

Clinical tests: No clinical tests were performed.

Conclusion: It is concluded that because the ENDOR 2000 was designed like the 804S III keeping all electrical parameters alike (and even using similar circuitry), that it is substantially equivalent to the 804S III. It is reasonable to conclude that the ENDOR 2000 is as safe and effective as the 804S III. One however cannot claim that the ENDOR 2000 is better.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 7 2000

Mr. Lincoln Ong President TC Medical, Inc. 14710 Orchard Road Minnetonka, Minnesota 55345

K984376/S3 Re: Trade Name: EnDor™ 2000 TENS Device Regulatory Class: II Product Code: 84 GZJ Dated: April 5, 2000 Received: April 13, 2000

Dear Mr. Ong:

We have reviewed your Section 510(k) notification of intent to market the device referenced above we have reviewed your beeness is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to the closed of the enactment date of the Medical Device Amendments, or to devices that have been rear 20, 1976, the charge with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may, therefere, manno 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your I tpp. o war, a may of our of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at

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## Page 2 - Mr. Lincoln Ong

[phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

une R. lochner-

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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Page 1 of 1

K984376 510(k) Number:

Device Name: EnDor™ 2000 TENS Device

Indications For Use:

Symptomatic relief and management of chronic (long-term) intractable pain and as an adjunctive treatment in the management of post surgical and post traumatic acute pain problems.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Donna R. Vachner.

(D. Brion Sign-Off) Di of General Restorative Devices 51. Number K 98437

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use

(Optional Format 1-2-96)