(32 days)
Useful for physiotherapy in redevelopment of muscles or for restoration of motion to joints or for use as an adjunct treatment for obesity. The bicycle would be Class I exempt when sold without measuring capability but is available with ECG and/or blood pressure measuring options thus making it Class II, not exempt. The unit's workload can be controlled by an RS-232 input for connection to ECG stress test systems (supplied by other manufacturers)
Not Found
The provided text does not contain information about acceptance criteria or a study proving that a device meets such criteria. The document is a 510(k) premarket notification for an exercise bicycle (REHCOR™) and discusses its classification, indications for use, and substantial equivalence to a predicate device, but it does not detail any performance studies with specific acceptance criteria.
Therefore, I cannot fulfill your request for the tables and information regarding acceptance criteria and a study from the provided text.
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4/12/99
EXHIBIT 1
General Information
a) Trade name /Proprietary Name: REHCORTM
b) Common name /Usual Name: Exercise Bicycle
c) Establishment registration number: ElectraMed will register (as initial importer) prior to marketing the device. The manufacturing company is FDA registered, number: 9019791
d) Address of manufacturer:
Lode B.V. Medical Technology. Zernikepark 16 9747 AN Groningen The Netherlands Tel. 011-31-(0) 50-5712811 Fax 011-31-(0) 50-5716746
e) Device class: Class II per Regulation 890.5360, Measuring exercise equipment
Classification Name/Product Code: Measuring exercise equipment , Product code ISD
f) New or Modification: This notification is for a new device for the USA market. The product bears the CE mark and is legal for sale in Europe.
g) Predicate Devices (Substantial Equivalence): Lode Model Corival Ergometer, K851097
h) 513/514 Compliance (Performance Standard): None established under section 514. Complies with IEC 60601-1 Medical Electrical Equipment, Part 1: General requirements for safety, 1. Collateral standard: Safety requirements for medical electrical systems and ISO 9001/EN 46001 Standards.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol. The logo is presented in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 2 1999
Daniel Kamm, P.E. Kamm & Associates Representing Electramed Corporation P.O. Box 7007 60015 Deerfield, Illinois
K990813 Re : REHCOR™ Trade Name: Requlatory Class: II Product Code: ISD March 10, 1999 Dated: March 11, 1999 Received:
Dear Mr. Kamm:
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. ਬ 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 In addition, FDA may publish further announcements action. 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 - Daniel Kamm, P.E.
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 Also, please note the Office of Compliance at (301) 594-4639. 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,
Celia M. Witten, Ph.D., M.D.
Director
Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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j) Indications for Use
510(k) Number
Device Name: Rehcor™
Indications for Use: Useful for physiotherapy in redevelopment of muscles or for restoration of motion to joints or for use as an adjunct treatment for obesity. The bicycle would be Class I exempt when sold without measuring capability but is available with ECG and/or blood pressure measuring options thus making it Class II, not exempt. The unit's workload can be controlled by an RS-232 input for connection to ECG stress test systems (supplied by other manufacturers)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR Over the Counter Use (Per 21 CFR 801.109)
còee
816990813
§ 890.5360 Measuring exercise equipment.
(a)
Identification. Measuring exercise equipment consist of manual devices intended for medical purposes, such as to redevelop muscles or restore motion to joints or for use as an adjunct treatment for obesity. These devices also include instrumentation, such as the pulse rate monitor, that provide information used for physical evaluation and physical planning purposes., Examples include a therapeutic exercise bicycle with measuring instrumentation, a manually propelled treadmill with measuring instrumentation, and a rowing machine with measuring instrumentation.(b)
Classification. Class II (special controls). The device, when it is a measuring exerciser or an interactive rehabilitation exercise device for prescription use only, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.