(56 days)
For adjunctive use in post-traumatic pain syndromes; for management and symptomatic relief of chronic (long-term) pain; as an adjunctive treatment in the management of post-surgical pain problems; relaxation of muscle spasms; prevention or retardation of tissue atrophy; increasing local blood circulation; muscle re-education; immediate postsurgical stimulation of calf muscles to prevent phlebothrombosis; and maintaining or increasing range of motion. To stimulate peripheral nerves for the purpose of providing pain relief and to stimulate motor nerves for the purpose of muscle rehabilitation.
Not Found
This document is a 510(k) premarket notification letter from the FDA regarding the "Hakomed Elecdt/Vacupulls" device. It is a regulatory approval letter and does not contain information about acceptance criteria or specific study details proving a device meets them.
The letter explicitly states:
"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"
This means the device was approved based on its substantial equivalence to a predicate device already on the market, rather than a new study demonstrating its performance against specific acceptance criteria.
Therefore, I cannot provide the requested information for the Hakomed Elecdt/Vacupulls device based on the provided text. The document does not contain:
- A table of acceptance criteria and reported device performance.
- Sample size, data provenance, number of experts, qualifications of experts, or adjudication method for a test set.
- Information on a Multi-Reader Multi-Case (MRMC) comparative effectiveness study or any effect size.
- Information on a standalone performance study.
- Details on the type of ground truth used.
- Sample size for a training set or how ground truth was established for it.
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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 11 1998
Mr. Kai Hansjurgens Alive Inc. 537 Cummins Street Honolulu, Hawaii 96814
K980958 Re : Hakomed Elecdt/Vacupulls Trade Name: Requlatory Class: II Product Codes: IPF and LIH Dated: March 5, 1998 March 16, 1998 Received:
Dear Mr. Hansjurgens:
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 The general controls provisions of the Act 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. ਜੋ 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.
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Page 2 - Mr. Kai Hansjurgens
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 (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Colin M. Whitten, Ph.D.
a M. Witten, Ph.D., M.D. Celi Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) NUMBER (IF KNOWN): K980958
HAKOMED ELECDT/VACUPULLS DEVICE NAME:
INDICATIONS FOR USE:
For adjunctive use in post-traumatic pain syndromes; for management and symptomatic relief of chronic (long-term) pain; as an adjunctive treatment in the management of post-surgical pain problems; relaxation of muscle spasms; prevention or retardation of tissue atrophy; increasing local blood circulation; muscle re-education; immediate postsurgical stimulation of calf muscles to prevent phlebothrombosis; and maintaining or increasing range of motion. To stimulate peripheral nerves for the purpose of providing pain relief and to stimulate motor nerves for the purpose of muscle rehabilitation.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
X
(Per 21 CFR 801.109)
OR
Over-The-Counter-Use_
(Optional Format 1-2-96)
(Div Sign-Off)
General Restorative Devices
By Number K980958
§ 890.5850 Powered muscle stimulator.
(a)
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.(b)
Classification. Class II (performance standards).