(266 days)
Not Found
No
The device description details a mechanical system with manually adjustable pressure settings and fixed cycle times. There is no mention of adaptive algorithms, learning capabilities, or data processing that would indicate the use of AI or ML.
Yes
The device is intended to temporarily relieve minor muscle aches and/or pains and to temporarily increase circulation to the treated areas, which are therapeutic claims.
No
The intended use of the device is to temporarily relieve minor muscle aches and pains and temporarily increase circulation, which are therapeutic functions, not diagnostic.
No
The device description explicitly details hardware components including an air compressor, inflatable sleeves/garments, a check valve, and a calibrated dial gauge. It is a physical device with mechanical and electrical components, not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for temporary relief of muscle aches/pains and increased circulation through external massage. This is a physical therapy/massage application, not a diagnostic test performed on biological samples.
- Device Description: The device is a mechanical system involving air pressure and inflatable garments applied externally to the body. It does not involve the analysis of biological specimens (like blood, urine, tissue, etc.).
- Lack of Biological Sample Analysis: There is no mention of collecting or analyzing any biological samples.
IVD devices are specifically designed to perform tests on biological samples to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Model 2004-OC and 2008-OC Massage Systems are powered inflatable tube massagers intended to temporarily relieve minor muscle aches and to temporarily increase circulation to the treated areas. The device is intended for home use by people who are in good health.
Product codes
IRP
Device Description
The device consists of an air compressor with manually adjustable pressure settings (i.e., the user manually adjusts the pressure, while the inflate/deflate cycle times remain constant) and a sleeve or garment containing four (2004-OC) or eight (2008-OC) discrete, segmented inflatable chambers externally applied to the limb.
The pump consists of a compressor capable of a maximum pressure of 150 mmHg, and provides graduated, or gradient, pressurization to the chambers (e.g., sequential inflation of distal to proximal, with distal chambers inflated to a greater pressure than the proximal ones).
An in-line check valve limits the output pressure to 80 mmHg, and a calibrated dial gauge displays pressure in the range of 0-125 mmHq.
As each chamber is inflated, the pressure is held constant until all chambers are inflated, in order to prevent reverse gradient flow. Once all chambers are inflated, they are then all released simultaneously, and the cycle repeats. Pressures within the distal chambers have a default value set at the factory (60 mmHg distal), and can be adjusted by the user to distal pressures between 30 mmHg and 80 mmHg. Pressures decrease by 5 mmHg in each proximally sequential chamber.
Garments are available in sizes to accommodate varying limb lengths. An adapter is available to support bilateral treatment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
limb
Indicated Patient Age Range
Not Found
Intended User / Care Setting
home use by people who are in good health.
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
Before being released, every device is tested and must meet all performance specifications. In addition to aesthetic acceptance criteria, functional testing includes electrical leakage, inflation pressure in each segment, pressure adjustment, pressure gradient across the segments, air pressure gauge accuracy, and inflation/deflation cycle times.
Key Metrics
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
11. 510(k) Summary
APPLICANT'S INFORMATION
Robert Freidenrich, CEO Bio Compression Systems, Inc 120 West Commercial Avenue Moonachie, NJ, 07074 201 939-0716 PH: 201 939-4503 FX: E-mail: Internet: http://www.biocompression.com Medical Establishment Registration No .:
2424387
SUBMITTER'S INFORMATION
Maureen Garner, President New World Regulatory Solutions, Inc. P.O. Box 5374 Toms River, NJ 08754 732-779-7422 PH: 732-270-4829 Fax: E-mail: Internet: www.newworldreg.com
DATE PREPARED: March 29, 2013
DEVICE INFORMATION
| DEVICE NAME: | 2008-OC and 2004-OC Massage Systems |
|---|---|
| Classification Panel: | Surgical, Orthopedic and Restorative Devices |
| Classification Number: | 890.5650 |
| Product Nomenclature: | Powered Inflatable Tube Massager |
| Product Code(s): | IRP |
| Trade/Proprietary Name: | 2008-OC Massage System |
| 2004-OC Massage System | |
| Common Name: | 2008-OC Massage System |
| 2004-OC Massage System |
DEVICE CLASSIFICATION
Powered Inflatable Tube Massager Devices are classified as Class II devices, and reviewed by the Division of Surgical, Orthopedic and Restorative Devices.
PREDICATE DEVICE
DJS Massager (K112479; product code IRP) manufactured by Mego Afec AC LTD.
DEVICE DESCRIPTION
The device consists of an air compressor with manually adjustable pressure settings (i.e., the user manually adjusts the pressure, while the inflate/deflate cycle times remain constant) and a sleeve or garment containing four (2004-OC) or eight (2008-OC) discrete, segmented inflatable chambers externally applied to the limb.
The pump consists of a compressor capable of a maximum pressure of 150 mmHg, and provides graduated, or gradient, pressurization to the chambers (e.g., sequential inflation of distal to proximal, with distal chambers inflated to a greater pressure than the proximal ones).
APR 0 9 2013
1
An in-line check valve limits the output pressure to 80 mmHg, and a calibrated dial gauge displays pressure in the range of 0-125 mmHq.
As each chamber is inflated, the pressure is held constant until all chambers are inflated, in order to prevent reverse gradient flow. Once all chambers are inflated, they are then all released simultaneously, and the cycle repeats. Pressures within the distal chambers have a default value set at the factory (60 mmHg distal), and can be adjusted by the user to distal pressures between 30 mmHg and 80 mmHg. Pressures decrease by 5 mmHg in each proximally sequential chamber.
Garments are available in sizes to accommodate varying limb lengths. An adapter is available to support bilateral treatment.
INDICATIONS FOR USE
The Model 2004-OC and 2008-OC Massage Systems are powered inflatable tube massagers intended to temporarily relieve minor muscle aches and to temporarily increase circulation to the treated areas. The device is intended for home use by people who are in good health.
TECHNOLOGICAL CHARACTERISTICS
The manufacturer believes that the technological characteristics of the 2004-OC Massage Systems are substantially similar to those of the predicate device.
PERFORMANCE DATA
Before being released, every device is tested and must meet all performance specifications. In addition to aesthetic acceptance criteria, functional testing includes electrical leakage, inflation pressure in each segment, pressure adjustment, pressure gradient across the segments, air pressure gauge accuracy, and inflation/deflation cycle times.
STATEMENT OF SUBSTANTIAL EQUIVALENCE
The Bio Compression Systems Model 2004-OC and 2008-OC Massage Systems and the predicate device all provide sequential inflation pressure from distal to proximal segments. Both the Bio Compression and predicate devices offer adjustable pressure ranges.
The Bio Compression devices have decreasing gradient pressures from distal to proximal segments, which prevent flow of lymph back into the limb, while predicate device does not have decreasing gradient pressures. The Bio Compression devices provide continuously adjustable pressure in the range between 30 to 80 mmHg. while the predicate device provides three pressure adjustments options in increments of low, medium and high pressure ranges within the 20 to 80 mmHg range. The Bio Compression devices have fixed cycle times that are fixed by a motorized valve, and are independent of garment size and number (one or two garments). The predicate device does not have a motorized valve and uses back pressure to trigger the cycle to the next chamber of the garment.
Both the Bio Compression devices and the applicant device operate within clinically-established parameters. The differences between the predicate and the applicant devices do not impact safety or effectiveness. A table illustrating the similarities and differences is provided below.
2
Similarities and Differences with the Predicate Device
| Parameter | 2004-OC | 2008-OC | K112479
DJS Massager |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------|-----------------------------------------------------------------------|
| Intended Use | Temporarily relieve minor muscle aches and/or pains, and to temporarily increase
circulation to the treated areas. The devices are intended for home use by people
who are in good health. | | |
| Principal of
Operation | Sequential pneumatic
compression | Same | Same |
| Weight | 8 pounds | 8 pounds | 5.1 pounds |
| Dimensions, inches | 5.5H X 8 L X 12 W | 5.5H X 8 L X 12 W | 3.9 H X 10.2 L X 5.1 W |
| # of Segments in
garment | 4 | 8 | 4 |
| Sequential segment
inflation | Yes | Yes | Yes |
| Distal to Proximal
gradient | Yes | Yes | No |
| Inflation Time, each
segment | 18 seconds | 5.5 seconds | Approx. 10 (one garment)
or 18 (two garments)
seconds |
| Inflation Pressure | 30 - 80 mmHg distal,
adjustable in 1 mmHg
increments | 30 - 80 mmHg distal,
adjustable in 1 mmHg
increments | 20 - 80 mmHg, adjustable
in 3 ranges: 20-30, 40-60
and 70-80 |
| Locking pressure
adjustment knob | Yes | Yes | Yes |
| Pressure Gauge | Yes, 0 - 125 mmHg | Yes, 0 - 125 mmHg | No |
| Deflation Time | 18 seconds | 5.5 seconds | Approx. 10 (one garment)
or 18 (two garments)
seconds |
| Pause time between
inflation cycles | None (deflation time is
pause time) | None (deflation time is
pause time) | Adjustable in 3 levels:
10-20, 30-50 and 60-70
seconds |
| Total Cycle Time | 90 seconds, fixed
(one or two garments). | 50 seconds, fixed
(one or two garments) | Variable: Approx. 50
(one garment) or 90
seconds (two garments) |
| Garments Available | Sized leg and
arm/shoulder | Same | Same |
| Fail-safe hose
connectors | Yes | Yes | Yes |
| Bilateral Treatment
Option | Yes | Yes | Yes |
| Power Requirements | 115VAC, 50-60Hz | Same | Same |
Based upon safety and performance testing, compliance with voluntary standards, and comparison to the predicate devices, the manufacturer believes that the 2004-OC and 2008-OC Massage Systems are substantially equivalent to the predicate device, and do not raise any new questions of safety or effectiveness.
3
Image /page/3/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring three curved shapes, resembling a stylized caduceus or a representation of human figures.
April 9, 2013
Bio Compression Systems, Inc. c/o Ms. Maureen N. Garner President 1983 Hazelwood Road Toms River, NJ 08754
Re: K122112/S001
Trade/Device Name: 2004-OC Massage System, 2008-OC Massage System Regulation Number: 21 CFR 890.5650 Regulation Name: Powered Inflatable Tube Massager Regulatory Class: Class II Product Code: IRP Dated: April 1, 2013 Received: April 2, 2013
Dear Ms. Garner:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-002
4
Page 2 - Ms. Maureen N. Garner
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Joyce M. Whang -S
for Victor Krauthamer, Ph.D. Acting Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K122112
Device Name: 2004-0C Massage System, 2008-0C Massage System
Indications For Use:
The 2004-0C and 2008-0C Massage Systems are powered inflatable tube massagers intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas. The devices are intended for home use by people who are in qood health.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Joyce M Whang -
(Division Sign Off) Division of Neurological and Physical Medicine Devices (DNPMD)
510(k) Number _K122112
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