(184 days)
No
The device description and intended use do not mention any computational or algorithmic features that would suggest the use of AI or ML. The device appears to be a purely mechanical and electrical massager.
Yes
The device description explicitly states it is an "electrically powered therapeutic massager," and its intended uses include "relief of minor muscle aches and pains," "relief of muscle spasm," and "temporary improvement of local circulation," all of which are therapeutic indications. Additionally, it lists a predicate device that is also a "Therapeutic Massager."
No
The TherMassager is described as a therapeutic massager intended for relief of muscle aches, pain, spasms, and to improve circulation and the appearance of cellulite. Its functions are physical therapy and aesthetic in nature, not diagnostic (identifying or characterizing a disease or condition).
No
The device description clearly outlines a physical, hand-held unit with a housing, suction pump, massage motor, and skin rollers, indicating it is a hardware device, not software-only.
No, the TherMassager is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens from the human body. This includes things like blood, urine, tissue, etc., to provide information about a person's health.
- The TherMassager is a therapeutic massager. Its intended use is for physical application to the body to provide relief from muscle aches, spasms, and improve circulation and the appearance of cellulite. It does not involve the analysis of any biological specimens.
The description clearly indicates it's a physical device for external application, not for laboratory testing of samples.
N/A
Intended Use / Indications for Use
- Relief of minor muscle aches and pains
- Relief of muscle spasm
- Temporary improvement of local circulation (i.e., blood circulation)
- Temporary improvement in the appearance of cellulite
Product codes
ISA, GEI
Device Description
The TherMassager is a self-contained, 9.0 VIDC electrically powered therapeutic massager. The basic configuration is that of an ergonomically rounded hand-held box-like unit. Weight is approximately 4 pounds. The housing is made from medical grade plastic and contains a suction pump, a massage motor and skin rollers. The outside of the unit is affixed with a strap which may be secured over the operators hand to provide additional grip during treatment application. Three treatment rollers are supplied with each unit. The TherMassager unit has I spiral roller, 1 ribbed roller and 1 lobed (contoured) roller. The rollers are made from medical grade silicone elastomer meeting ISO 10993 biocompatibility standards.
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)
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
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.
0
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| Summary of 510(k) Information
Premarket Notification, Section 510(k) | | | | THERMAGE, INC.
OCTOBER 6, 2006 |
|-------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------|--|-----------------------------------|
| | Regulatory Authority: | Safe Medical Devices Act of 1990, 21 CFR 807.92 | | |
| 1. | Device Name: | | | |
| | Trade Name: | TherMassager | | OCT 12 2006 |
| | Common
Name(s): | Therapeutic massager | | |
| | Classification
Name(s): | Therapeutic massager | | |
| 2. | Establishment Name & Registration Number: | | | |
| | Name: | Thermage, Inc. | | |
| | Number: | 2954746 | | |
| 3. | Classification(s): | | | |
| | Sec. § 890.5660
(a) Identification. A therapeutic massager is an electrically powered device intended for medical
purposes, such as to relieve minor muscle aches and pains. | | | |
| | Device Class: | Class I for all requested indications | | |
| | Classification Panel: | Physical Medicine | | |
| | Product Code(s): | ISA | | |
Equivalent Predicate Device: 4.
Thermage believes that the TherMassager is substantially equivalent to the massage system identified below:
I. UPC Therapeutic Massager, K990445, LPG, USA, Inc.
Device Description: 5.
The TherMassager is a self-contained, 9.0 VIDC electrically powered therapeutic massager. The basic configuration is that of an ergonomically rounded hand-held box-like unit. Weight is approximately 4 pounds. The housing is made from medical grade plastic and contains a suction pump, a massage motor and skin rollers. The outside of the unit is affixed with a strap which may be secured over the operators hand to provide additional grip during treatment application. Three treatment rollers are supplied with each unit. The TherMassager unit has I spiral roller, 1 ribbed roller and 1 lobed (contoured) roller. The rollers are made from medical grade silicone elastomer meeting ISO 10993 biocompatibility standards.
1
Table of device characteristics.
| Feature | TherMassager | LPG | SF? |
|---|---|---|---|
| Indications for Use | Relief of minor musele aches and pains | ||
| Relief of musele spasm | |||
| Temporary improvement of local circulation | |||
| (i.e., blood circulation) | |||
| Temporary improvement in the uppearunce of | |||
| cellulite | SAME | y ES | |
| Power Requirements | AC/DC Aduptor | ||
| Input = 120 VDC - 60 Hz | |||
| Output = 9 VDC | 120 VAC -- 60 ILz | YES | |
| Weight: | |||
| Massager | |||
| AC/DC Adapter | 1.8 Kg | ||
| .5 Kg | 2 Kg - Handpiece only | yes | |
| Leakage Current | =50 micump |