(354 days)
None
No
The device description focuses on mechanical and electrical components (vacuum pump, motorized rollers, regulation system) and different modes of operation (constant/sequential aspiration) based on pressure levels. There is no mention of AI, ML, image processing, or data-driven decision-making.
Yes
The "Intended Use / Indications for Use" section explicitly states purposes such as "Reduction of Secondary Lymphedema" and "Improvement of lymphatic circulation," which are therapeutic goals. Additionally, the device is described as an "electrical therapeutic massager."
No
Explanation: The device description and intended use clearly state that it is a therapeutic massager for reducing lymphedema and improving lymphatic circulation, not for diagnosing any medical condition.
No
The device description explicitly details hardware components including a program console, vacuum pump, regulation system, and motorized rollers, indicating it is a physical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the reduction and improvement of lymphedema and lymphatic circulation through mechanical massage. This is a therapeutic application, not a diagnostic one.
- Device Description: The device is a therapeutic massager that uses vacuum and rollers to perform a massage technique. It does not involve analyzing biological samples (blood, urine, tissue, etc.) to diagnose a condition.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting biomarkers, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
Reduction of Secondary Lymphedema of the Arm (SLA) Post Mastectomy Improvement of Secondary Lymphedema Improvement of lymphatic circulation in the treated area
Product codes
ISA - IRO
Device Description
The Cellu M6 Keymodule i electrical therapeutic massager is comprised of a program console housing a vacuum pump and a regulation system. The main treatment head 150 consists of two parallel motorized rollers housed in a chamber which produces both negative pressure above the rollers and positive pressure below the rollers. This technology creates a skin fold between the two rollers in a suction chamber. thus mimicking the "rolled palpation" of manual massage techniques.
In addition to Head i50 which is meant primarily for the upper arm and for legs, auxiliary heads T615, T615-A, T630, T630-A, T644 and T644-A are also used, as they better suit smaller morphology (parts) of the body. Details are provided along the labeling provided.
This device has the capability to produce both constant and sequential aspiration. Constant aspiration provides a deeper massage, which also mobilizes the muscle fascia. With sequential aspiration, the suction power is cyclically interrupted to provide pulsation to the skin fold between the two rollers and a softer, gentler stroking action of the tissues.
The suction power ranges from 45 mm Hg to 180 mmHg, which is represented by a power level scale ranging from 1 to 4.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper arm and for legs, smaller morphology (parts) of the body, Arm, treated area
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
K990445, K912004, K914774, K974395, K043423, K013061
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 890.5660 Therapeutic massager.
(a)
Identification. A therapeutic massager is an electrically powered device intended for medical purposes, such as to relieve minor muscle aches and pains.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9.
0
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NOV - 6 ZUiJb
510(k) Summary As Required by 21 section 807.92 ( c )
1-Submitter Name: LPG One, Inc
801 Brickell Ave. Suite 850. Miami, FL 33131 2-Address:
(305) 379- 8800 3-Phone:
(305) 375- 0903 4-Fax:
5-Contact Person (Consultant): Jay Mansour of Mansour Consulting LLC
845 Aronson Lake Court
Roswell, GA 30075 USA
- (678) 908-8180. Fax (678) 623-3765
6-Date summary prepared: September 16th, 2006
7-Device Trade or Proprietary Name: CELLU M6 KEYMODULE i
8-Device Common or usual name: Massager
9-Device Classification Name: Electrical Therapeutic Massager
10-Substantial Equivalency is claimed against the following devices:
- 1- LPG One (formerly LPG USA) ES1 Massager- 510k #K990445
11-Description of the Device:
The Cellu M6 Keymodule i electrical therapeutic massager is comprised of a program console housing a vacuum pump and a regulation system. The main treatment head 150 consists of two parallel motorized rollers housed in a chamber which produces both negative pressure above the rollers and positive pressure below the rollers. This technology creates a skin fold between the two rollers in a suction chamber. thus mimicking the "rolled palpation" of manual massage techniques.
In addition to Head i50 which is meant primarily for the upper arm and for legs, auxiliary heads T615, T615-A, T630, T630-A, T644 and T644-A are also used, as they better suit smaller morphology (parts) of the body. Details are provided along the labeling provided.
This device has the capability to produce both constant and sequential aspiration. Constant aspiration provides a deeper massage, which also mobilizes the muscle fascia. With sequential aspiration, the suction power is cyclically interrupted to provide pulsation to the skin fold between the two rollers and a softer, gentler stroking action of the tissues.
The suction power ranges from 45 mm Hg to 180 mmHg, which is represented by a power level scale ranging from 1 to 4.
12-Intended use of the device: (refer to FDA form attached)
The intended uses of this device are:
Page 3.1
1
page 2 of 2
Reduction of secondary lymphedema of the Arm (SLA) Post Mastectomy Improvement of secondary lymphedema Improvement of lymphatic circulation in the treated area
13-Safety and Effectiveness of the device:
This device is safe and effective as the predicate devices cited above. This is better expressed in the tabulated comparison (Paragraph 14 below)
14-Summary comparing technological characteristics with predicate device:
Please find below a tabulated comparison supporting that this device is substantially equivalent to other medical devices in commercial distribution. Also, Equivalency overview chart path is attached. Indeed, this device is SUBSTANTIALLY EQUIVALENT to the predicate devices. Refer to the explanations/details within the main submission.
| FDA file reference number | 510k # K912004, K914774, K974395, K043423 and K013061 510k #K990445 | ||
|---|---|---|---|
| TECHNOLOGICAL CHARACTERISTICS | Comparison result of this device with the predicate devices | ||
| Indications for use | Identical | Different | |
| Target population | Identical | Different | |
| Design | Similar in terms of mode of action | Very similar | |
| Materials | |||
| Performance | |||
| Sterility | Not applicable | ||
| Biocompatibility | Similar | ||
| Mechanical safety | |||
| Chemical safety | Not applicable | ||
| Anatomical sites | Similar | Similar | |
| Human factors | Similar | ||
| Energy used and/or delivered | Very similar | ||
| Compatibility with environment and other devices | Identical | ||
| Where used | Similar | ||
| Standards met | Very similar | ||
| Electrical safety | Very similar | ||
| Thermal safety | NOT APPLICABLE | ||
| Radiation safety |
Refer to the submission for more details.
PAGE 3.2
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
LPG One, Inc. C/o Jay Mansour, MSQA, BE, RAC President, Mansur Consulting, LLC 845 Aronson Lake Court Roswell, GA 30075
NOV - 6 2006
Re: K053225
Trade/Device Name: Cellu M6 Keymodule i Regulation Number: 21 CFR 890.5665 Regulation Name: Therapeutic Massager Regulatory Class: 21 CFR 890.9 - Limitations of exemptions from section 890.5660 - Class I Product Code: ISA - IRO Dated: June 23, 2006 Received: July 3, 2006
Dear Mr. Mansour:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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); 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.
3
Page 2 - Mr. Jay Mansour
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours.
Mark N. Melkerson, M.S. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
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Page 3 -- Mr. Jay Mansour
Enclosure
cc: HFZ-401 DMC -HFZ-404 510(k) Staff HFZ- 410 DGRND D.O.
.
:
f/t: DXV: 10- 31-06
. .
5
Indications for Use
510(k) Number (if known): K053225
Device Name: CelluM6 Keymodule i
Indications For Use:
Reduction of Secondary Lymphedema of the Arm (SLA) Post Mastectomy Improvement of Secondary Lymphedema Improvement of lymphatic circulation in the treated area
ﻤﺴﺎﻫﻤﺔ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮ Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use __ (21 CFR 807 Subpart C)
f
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| L053225 | |
| (Division Sign-Off) | |
| Division of General, Restorative, Page 1 of 1 | |
| and Neurological Devices | |
| 510(k) Number | K053225 PAGE 4.1 |