(67 days)
Not Found
No
The device description details a purely mechanical system for intermittent compression using air pressure and chambers, with no mention of computational processing, algorithms, or learning capabilities.
Yes
The device is intended to relieve minor aches and pains and to increase circulation, which are therapeutic claims.
No
Explanation: The device is described as an intermittent compression boot intended for first aid treatment of minor sports injuries, to relieve minor aches and pains, and to increase circulation. It applies pressure to the lower limbs to simulate kneading and stroking of tissues. The provided text does not mention any diagnostic capabilities, such as identifying, detecting, or monitoring medical conditions or diseases.
No
The device description clearly outlines a physical, inflatable boot with chambers, air passageways, a hand pump port, and a valve stem. This indicates a hardware-based medical device, not a software-only one.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device function: The EISCHO Intermittent Compression Boot is a physical therapy device that applies external pressure to the lower limbs. It does not analyze any biological samples.
- Intended Use: The intended use is for physical treatment (relieving aches and pains, increasing circulation) through mechanical compression, not for diagnostic testing.
Therefore, based on the provided information, the EISCHO Intermittent Compression Boot falls under the category of a physical therapy or rehabilitation device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The EISCHO Intermittent compression Boot is intended for medical purposes, such as to relieve minor aches and pains and to increase circulation in the patient's lower limbs. It simulates kneading and stroking of tissues by using an inflatable pressure cuff. The boot is not life sustaining is not implanted and does not use software. It is constructed of plastic that is designed for use over the lower extremity. It appears as an inflated boot. There are no toxicology implications. It is not sterile and is intended for the use of one person. The device is for home, hospital or clinical use. There are no drug or biological components.
Product codes
IRP
Device Description
This device is an inflatable garment or boot that is intended for use on patients' lower limbs. It consists of two chambers. The upper chamber envelops the lower extremity and the lower chamber is located under the foot.
The interior panel has been sealed onto the exterior panel. When pressure is applied to the lower chamber by the patient's foot, air moves from the lower chamber to the upper chamber through the air passageways shaded in blue.
The boot is placed on the patient and then inflated by attaching a hand pump to the port at the top of the boot. The boot is then inflated by means of the patient placing pressure on the foot.
At this point, the pressure in the upper chamber increases which causes a compression of the limb. When the patient lifts his/her foot, the air passes from the upper chamber to inflate the lower chamber, which causes the overall boot pressure to return to nominal pressure. The pressure may be applied while walking, standing, sitting or lying.
The patient repeats this process until the therapy session is completed. To deflate the boot, the patient presses inward on the valve stem with his/her finger or uses the cap that is attached to the valve. The deflated boot is then easily removed.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lower limbs, lower extremity, foot, ankle, lower leg
Indicated Patient Age Range
Not Found
Intended User / Care Setting
home, hospital or clinical use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 890.5650 Powered inflatable tube massager.
(a)
Identification. A powered inflatable tube massager is a powered device intended for medical purposes, such as to relieve minor muscle aches and pains and to increase circulation. It simulates kneading and stroking of tissues with the hands by use of an inflatable pressure cuff.(b)
Classification. Class II (performance standards).
0
991921/
1. Submitter:
Clem Eischen Owner EISCHO, Inc. 1232 S.E. 282 Ave. Grisham, OR 97080 Tel: (503) 2232 Fax: (503) 2232
Device Name 2.
- Classification: 2.1
- 2.2 Common/Usual Name:
- Proprietary Name: 2.3
Panel 74, Class II, 890.5650 Power Inflatable Tube Messager Intermittent Compression Boot
Predicate Device: 3.
- 3.1 EISCO, Inc.'s Intermittent Compression Boot for professional use, K964957
4. Intended Use:
The EISCHO Intermittent compression Boot is intended for medical purposes, such as to relieve minor aches and pains and to increase circulation in the patient's lower limbs. It simulates kneading and stroking of tissues by using an inflatable pressure cuff. The boot is not life sustaining is not implanted and does not use software. It is constructed of plastic that is designed for use over the lower extremity. It appears as an inflated boot. There are no toxicology implications. It is not sterile and is intended for the use of one person. The device is for home, hospital or clinical use. There are no drug or biological components. See also exhibit 6, product labels, for indications for use.
స్ Device Description:
This device is an inflatable garment or boot that is intended for use on patients' lower limbs. It consists of two chambers. The upper chamber envelops the lower extremity and the lower chamber is located under the foot.
The interior panel has been sealed onto the exterior panel. When pressure is applied to the lower chamber by the patient's foot, air moves from the lower chamber to the upper chamber through the air passageways shaded in blue.
The boot is placed on the patient and then inflated by attaching a hand pump to the port at the top of the boot. The boot is then inflated by means of the patient placing pressure on the foot..
At this point, the pressure in the upper chamber increases which causes a compression of the limb. When the patient lifts his/her foot, the air passes from the upper chamber to inflate the
1
EISCHO, Inc. Intermittent Compression Boot Premarket Notification Summary Of Data
lower chamber, which causes the overall boot pressure to return to nominal pressure. The pressure may be applied while walking, standing, sitting or lying.
The patient repeats this process until the therapy session is completed. To deflate the boot, the patient presses inward on the valve stem with his/her finger or uses the cap that is attached to the valve. The deflated boot is then easily removed.
6. Substantial Equivalency Comparisons:
The comparison of EISCHO's Intermittent Compression Boot for over the counter use and EISCHO's Intermittent Compression Boot for professional use K964957 are the same The intermittent compression boot for over the counter use is indicated for first aid use on minor sports injuries and the intermittent compression boot for professional use is indicated for post phlebitis syndrome; swelling of foot, ankle and lower leg due to total knee replacement; bruising, swollen knee and ankle; and gravitational edema after cast removal.
7. Conclusions:
Comparison of EISCHO's Intermittent Compression Boot for over the counter use and EISCHO's Intermittent Compression Boot for professional use indicates that they are substantially equivalent. The intermittent compression boot for over the counter use is use for first aid minor injuries. This poses no new safety of functional issues.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. The text is in all caps and appears to be in a sans-serif font.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 13 1999
Mr. Clem Eischen President/Sales Eischco, Incorporated 1232 S.E. 282nd Avenue Gresham, Oregon 97080
Re: K991921
Trade Name: Intermittent Compression Boot for OTC Regulatory Class: II Product Code: IRP Dated: May 28, 1999 Received: June 7, 1999
Dear Mr. Eischen:
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 control provisions of the Act. The general control 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.
3
Page 2 – Mr. Clem Eischen
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. Witten, Ph.D., M.D.
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
4
Indications for Use Statement
K991921 Unknown
510(k) Number (if known):
Intermittent Compression Boot For Over The Counter Use
Device Name:
Indications For Use:
The EISCHO Intermittent compression Boot is intended for first aid treatment of minor sportrs injuries. It is intended to relieve minor aches and pains and to increase circulation in the patient's lower limbs. It simulates kneading and stroking of tissues by using an inflatable pressure cuff.
. . .
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter USE X
tcaief
Division Sign-Off) ivision of General Restorative Devic 510/k) Number