(133 days)
Not Found
No
The document describes a standard electrotherapy device (NMES, TENS, Pulsed Current, FES) with no mention of AI or ML capabilities in the intended use, device description, or other sections.
Yes
The device is indicated for various medical conditions, including pain relief, muscle therapy, and edema reduction, which are therapeutic purposes.
No
The document describes the device's intended use for therapeutic purposes like pain relief, muscle re-education, and increasing range of motion, rather than for diagnosing medical conditions.
No
The intended use and predicate devices clearly indicate this is an electrotherapy system (NMES, TENS, Pulsed Current, FES), which requires hardware to deliver electrical stimulation. The lack of a device description doesn't negate the need for hardware based on the stated functions.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The provided description clearly indicates that this device is an electrotherapy system with multiple functions (NMES, TENS, Pulsed Current, FES). These functions involve applying electrical stimulation to the body for therapeutic purposes, such as pain relief, muscle rehabilitation, and improving gait.
- Intended Use: The listed indications for use all relate to treating conditions within the body through electrical stimulation, not analyzing samples taken from the body.
Therefore, this device falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
As an NMES device, indications are for the following conditions:
- · Retarding or preventing disuse atrophy
- · Maintaining or increasing range of motion
- · Re-educating muscles
- · Relaxation of muscle spasms
- Increasing local blood circulation
- · Prevention of venous thrombosis of the calf muscles immediately after surgery
As a TENS device, indications are for the following conditions:
- · Symptomatic relief and management of chronic, intractable pain
- · Adjunctive treatment for post-surgical and post-trauma acute pain
- · Relief of pain associated with arthritis
As a Pulsed Current device, indications are for the following conditions:
- · Reduction of edema (under negative electrode)
- · Reduction of muscle spasm
- · Influencing local blood circulation (under negative electrode)
- · Retardation or prevention of disuse atrophy
- · Facilitation of voluntary motor function
- · Maintenance of increase of range of motion
As an FES device, the indications for the following condition:
• Stimulation of the leg and ankle muscles of partially paralyzed patients to provide flexation of the foot, thus improving the patient's GAIT.
Product codes (comma separated list FDA assigned to the subject device)
IPF, GZI, GZJ, LIH, NYN
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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.
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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
§ 890.5850 Powered muscle stimulator.
(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).
0
510 (k) : K093324
MAR - 5 2010
Section 4: 510(k) Summary per 21 CFR 807.92
SUBMITTER:
Empi Inc. 205 Hwy 22 East Clear Lake, SD 57226
ESTABLISHMENT REGISTRATION: 1721293
CONTACT: Virginia L. Conger, Director of Quality and Regulatory
PROPRIETARY NAME: Empi Continuum
CLASSIFICATION: Class II
PRODUCT CODES: IPF, Powered muscle stimulator GZI, External functional neuromuscular GZJ, Transcutaneous electrical nerve LIH, Interferential current therapy NYN, Stimulator, electrical, transcutaneous, for arthritis
REGULATION NUMBER: 21 CFR 890.5850
PANEL:
Physical Medicine
Indications for Use:
As an NMES device, indications are for the following conditions:
- · Retarding or preventing disuse atrophy
- · Maintaining or increasing range of motion
- Re-educating muscles
- · Relaxation of muscle spasms
- Increasing local blood circulation
- Prevention of venous thrombosis of the calf muscles immediately after surgery
1
As a TENS device, indications are for the following conditions:
- Symptomatic relief and management of chronic, intractable pain
- Adjunctive treatment for post-surgical and post-trauma acute pain
- Relief of pain associated with arthritis
- As a Pulsed Current device, indications are for the following conditions:
- · Reduction of edema (under negative electrode)
- Reduction of muscle spasm
- Influencing local blood circulation (under negative electrode)
- · Retardation or prevention of disuse atrophy
- Facilitation of voluntary motor function
- · Maintenance of increase of range of motion
As an FES device, the indications for the following condition:
- Stimulation of the leg and ankle muscles of partially paralyzed patients to provide flexation of the foot, thus improving the patient's GAIT.
Substantially Equivalent Predicate Devices
| Predicate device(s): | 300PV Complete Electrotherapy System |
|---|---|
| 510(k) number: | K021100 |
| Date: | June 18, 2002 |
Additional Predicate Devices:
| Predicate device(s): | Empi SELECT TENS System |
|---|---|
| 510(k) number: | K061650 |
| Date: | February 22, 2007 |
| Predicate device(s): | REHABILICARE IF 3 WAVE INTERFERENTIAL STIMULATOR
SYSTEM |
|----------------------|------------------------------------------------------------|
| 510(k) number: | K050046 |
| Date: | April 13, 2005 |
2
Declarations of Conformity
The Empi Continuum devices comply with the following FDA recognized Consensus Standards:
- UL 60601-1: 2003, Standards for Medical Equipment Part 1: General . Requirements for Safety, 1st Edition
- IEC 60601-1-2: 2001 +Amendment 1:2004, Medical Electrical Equipment Part . 1 – 2: General requirements for Safety - Collateral Standard, Electromagnetic Compatibility - Requirements and Tests, 2nd Edition
- IEC 60601-2-10: 1987 +Amendment 1:2001, Medical Electrical Equipment -. Part 2-10: Particular Requirements for the safety of nerve and muscle stimulator
Truthful and Accurate Statement
A statement attesting to the truthfulness and accuracy of the information was included in the premarket submission.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its wing. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Empi, Inc. c/o Mr. Jo P. Chiu, MS, MBA Senior Regulatory Affairs Specialist Chattanooga Group 4717 Adams Road Hixson, TN 37343
MAR - 5 2010
Re: K093324
Trade/Device Name: EMPI Continuum Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: IPF Dated: February 19, 2010 Received: February 24, 2010
Dear Mr. Chiu:
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.
4
Page 2 - Mr. Jo P. Chiu, MS, MBA
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 yours,
Eile. Then, m k
Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number: Ko93334
Device Name: Empi Continuum
Indications for Use:
As an NMES device, indications are for the following conditions:
- · Retarding or preventing disuse atrophy
- · Maintaining or increasing range of motion
- · Re-educating muscles
- · Relaxation of muscle spasms
- Increasing local blood circulation
- · Prevention of venous thrombosis of the calf muscles immediately after surgery
As a TENS device, indications are for the following conditions:
- · Symptomatic relief and management of chronic, intractable pain
- · Adjunctive treatment for post-surgical and post-trauma acute pain
- · Relief of pain associated with arthritis
As a Pulsed Current device, indications are for the following conditions:
- · Reduction of edema (under negative electrode)
- · Reduction of muscle spasm
- · Influencing local blood circulation (under negative electrode)
- · Retardation or prevention of disuse atrophy
- · Facilitation of voluntary motor function
- · Maintenance of increase of range of motion
- As an FES device, the indications for the following condition:
• Stimulation of the leg and ankle muscles of partially paralyzed patients to provide flexation of the foot, thus improving the patient's GAIT.
| Prescription Use
| (Part 21 CFR 801 Subpart D) | √ |
|---|---|
| AND/OR | |
| Over-The-Counter Use | |
| (21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Tan L. Kawa
(Division Sign-Off) (Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K093324