GB-1002 TENS WITH MASSAGE

K964437 · Skylark Device Co., Ltd. · GZJ · Aug 14, 1998 · Neurology

Device Facts

• Record ID: K964437
• Device Name: GB-1002 TENS WITH MASSAGE
• Applicant: Skylark Device Co., Ltd.
• Product Code: GZJ · Neurology
• Decision Date: Aug 14, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

TRANSCUTANEOUS ELECTRICAL NERVE STIMULATION (TENS) DEVICES ARE USED FOR THE 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. A THERAPEUTIC VIBRATOR IS INTENDED FOR RELAXING MUSCLES AND RELIEVING MINOR MUSCLE ACHIES AND PAINS. FEDERAL LAW (USA) RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN. KEEP OUT OF THE REACH OF CHILDREN.

Device Story

GB-1002 TENS with Vibrator combines transcutaneous electrical nerve stimulation (TENS) and therapeutic vibration. TENS component delivers electrical pulses to skin to manage chronic intractable pain and acute post-surgical/post-traumatic pain. Vibrator component provides mechanical stimulation to relax muscles and relieve minor aches. Device intended for use under physician order. Clinical benefit derived from pain modulation via electrical stimulation and muscle relaxation via vibration.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on regulatory review of device notification.

Technological Characteristics

Dual-function device: TENS electrical stimulation and mechanical vibration. Prescription-only. Class II device (Product Code GZJ).

Indications for Use

Indicated for symptomatic relief and management of chronic intractable pain and as adjunctive treatment for post-surgical and post-traumatic acute pain. Therapeutic vibrator indicated for muscle relaxation and relief of minor muscle aches and pains. Prescription use only.

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.

Submission Summary (Full Text)

{0}

DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

AUG 14 1998

Mr. George K.C. Chen
President & CEO
Skylark Device Company Limited
12th Floor, 34, Section 3
Chung Shan North Road
Taipei, Taiwan

Re: K964437
Trade Name: GB-1002 Tens with Vibrator
Regulatory Class: II
Product Code: GZJ
Dated: May 15, 1998
Received: May 19, 1998

Dear Mr. Chen:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, 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.

{1}

Page 2 - Mr. George K.C. Chen

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 [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" (21 CFR 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/dsmamain.html".

Sincerely yours,

Mark N. Milken

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

Enclosure

{2}

510(k) Number (if known): K964437

Device Name: GB-1002 TENS WITH VIBRATOR

Indications For Use:

TRANSCUTANEOUS ELECTRICAL NERVE STIMULATION (TENS) DEVICES ARE USED FOR THE 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. A THERAPEUTIC VIBRATOR IS INTENDED FOR RELAXING MUSCLES AND RELIEVING MINOR MUSCLE ACHIES AND PAINS.

FEDERAL LAW (USA) RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN. KEEP OUT OF THE REACH OF CHILDREN.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark N. Millburn

(Division Sign-Off)

Division of General Restorative Devices

510(k) Number K964437

Prescription Use ☑ (Per 21 CFR 801.109)

OR

Over-The-Counter Use ☐

(Optional Format 1-2-90)