(342 days)
Not Found
No
The description mentions a "computerized regulation system" but provides no details suggesting AI/ML capabilities like learning, adaptation, or data-driven decision making beyond basic control. There are no mentions of AI, ML, or related concepts.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device "Relieves minor muscle aches and pains; Relieve muscle spasm; Temporarily Improve local circulation; Temporarily reduces the appearance of cellulite; Relieves minor muscle aches and pains, relieves muscle spasm and improves local circulation during Burn rehabilitation." These are all therapeutic claims. Furthermore, the "Device Description" mentions "therapeutic applications" for some models.
No.
The device's stated intended uses are for pain relief, circulation improvement, muscle spasm relief, and temporary reduction of cellulite appearance, none of which involve diagnosing a condition. Its description mentions therapeutic and cosmetic applications, not diagnostic ones.
No
The device description explicitly states that the devices comprise a main console housing a vacuum pump and a computerized regulation system, along with treatment heads. This indicates the presence of significant hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended uses listed are all related to physical therapy, pain relief, muscle treatment, and cosmetic applications (cellulite reduction). These are all applications performed on the body, not on samples taken from the body.
- Device Description: The device description details a physical therapy device that uses vacuum and vibration to treat the body surface. It does not mention any components or processes related to analyzing biological samples.
- Anatomical Site: The anatomical sites listed are all external parts of the body.
- Intended User/Care Setting: The intended users are practitioners like physicians and physical therapists, who typically perform treatments directly on patients.
- No mention of biological samples or analysis: There is no mention of collecting or analyzing blood, urine, tissue, or any other biological sample.
IVD devices are specifically designed 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
- Relieves minor muscle aches and pains ●
- . Relieve muscle spasm
- . Temporary improvement in local circulation
- . Temporarily reduces the appearance of cellulite
- Relieves minor muscle aches and pains, relieves muscle spasm and temporarily improves local . circulation during Burn rehabilitation
Product codes (comma separated list FDA assigned to the subject device)
89 ISA, 89 IRO
Device Description
The LPG technique involves a mobilization of the tissue accomplished with the LPG devices. All models with the exception of the ES1 and LPG Equine have both continuous and cyclic or pulsating modes of action. This pulsating function is equivalent to Therapeutic Vibrators (21 CFR 890.5975).
Each LPG device comprises a main console housing a vacuum pump and a computerized regulation system. All of them contain treatment heads (from 5 to 12), that are designed to accommodate all parts of the body. ES1, Cellu M6, S6, LPG Equine devices have a main motorized head, the other device contain auxiliary heads (non-motorized) only. The equine device head is the largest in order to be able to be applied on the horse's body surface. The suction power of all these machines range from 50mBar to 500mBar which is represented by a scale from 1 to 10; for a specific machine and application, the suction power must be cyclically interrupted to provide vibration to the skin which is another stimulation for the tissues. The motorized head contains two motorized rollers that move together and apart, at each end of the suction chamber. The two rollers are mobilized in rotation and in sliding back and forth. They provide, to the head, the capability of creating a fold of skin and subcutaneous fat with a very efficient contact, which allows better mobilization. In addition to the main head, a set of auxiliary heads can be used with two non-motorized rollers on smaller parts of the body. Recently, LPG had added small springs at each end of the rollers to provide lateral mobilization of them during the treatment. For a specific machine and application (Cellu M6, S6, M60, and LPG Equine), the suction power is cyclically interrupted to provide vibration to the skin fold between the two rollers, which is another form of stimulation for tissues. This cyclic pulsation feature is modulated by two variables: Cycle rate and Frequency.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Doctor Gavroy compared treatment on burn victim with LPG and rhythmicity and LPG without rhythmicity.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
LPG Therapeutic Massager (21 CFR 890.5660), G5-GK1 K850851, VIBRATOUCH II K912383
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
K99 0445
JAN 18 2000
510 (k) Summary
Applicant's Name: LPG USA
Applicant's Address: 3101 North Federal Highway (Suite (301) Fort Lauderdale, FL 33306
Contact Person: Walter L. Wasserman
Phone Number/contact person: (954)568-5005 Fax Number/contact person: (954)568-6611
Address of manufacturing site: LPG Systems Technoparc de la Plaine 30 Rue du Docteur Abel BP 35-26902 Valence Cedex 9, France
Date Summary Prepared: January 18, 2000
This summary includes sections 2 through 8.
1
2. Device Name
- Therapeutic Massager (21 CFR 890.5660) .
- Proprietary names LPG Therapeutic Massager Models ES1 .
- Therapeutic Massager/Vibrator (21 CFR 890.5660 and 890.5975) .
- Proprietary names LPG Therapeutic Massager/ Vibrator Models Cellu M6; ES/M60; S6; and LPG . Equine
3. Establishment registration number
1062948
- Classification of device 4.
- . Class I
- Product codes 89 ISA and 89 IRO .
- . Panel - Physical medicine
- ડ . Performance standards
There are no performance standards established under section 514
6. Labeling
6.1
Indications for use
- Relieves minor muscle aches and pains ●
- . Relieve muscle spasm
- . Temporary improvement in local circulation
- . Temporarily reduces the appearance of cellulite
- Relieves minor muscle aches and pains, relieves muscle spasm and temporarily improves local . circulation during Burn rehabilitation
Contraindications
- . Known sensitivity to the device
- Do not treat over open wounds .
- Skin cancer in the treated area .
- . Do not treat HIV positive patients
Caution
Federal law restricts thus device for sale to or use under of a licensed physician
Precautions;
When treating patients for burn rehabilitation care should be taken to carefully follow the instruction manual and not to exceed suction levels that would be obviously uncomfortable for the patient.
2
510(k) Number K99045 Device Name: LPG Therapeutic Massager/Vibrator
Intended uses
- Relieves minor muscle aches and pains .
- Relieve muscle spasm ●
- . Temporarily Improve local circulation
- Temporarily reduces the appearance of cellulite .
- Relieves minor muscle aches and pains, relieves muscle spasm and improves local circulation during . Burn rehabilitation
(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
1
Over-The-Counter-Use
(Optional Format 1-2-96)
6.2
3
7. Substantial equivalence comparison
This product is substantially equivalent to a product already on the market LPG Therapeutic Massager (21 CFR 890.5660). The LPG technique involves a mobilization of the tissue accomplished with the LPG devices. All models with the exception of the ES1 and LPG Equine have both continuous and cyclic or pulsating modes of action. This pulsating function is equivalent to Therapeutic Vibrators (21 CFR 890.5975). And as such Substantial Equivalence is also claimed to the following legally marketed devices, which are also Class I.
Table of Comparison
| Device | Indications | Design | Specifications |
|---|---|---|---|
| LPG Massager/Vibrator | Minor muscle pain | ||
| Relieve muscle spasm; Temp. | |||
| improvement in appearance of | |||
| cellulite; Temp. increase of | |||
| local circulation; Burn Rehab. | 5 models | ||
| 5 applicators | |||
| 12 treatment heads | |||
| 3 motorized heads | Ground current | ||
| Leakage |