(71 days)
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on mechanical design changes.
Yes
The device is used for the "treatment and management of muscle spasm and muscle tension," which indicates a therapeutic purpose.
No
The device is described as being used for the "treatment and management of muscle spasm and muscle tension" and its modifications do not change its "safety or effectiveness." There is no mention of it being used to identify or diagnose a condition.
No
The device description explicitly mentions physical modifications to the device, such as adding roller beads, handles, and interchangeable massage balls, 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 "in the treatment and management of muscle spasm and muscle tension." This describes a therapeutic or physical therapy application, not a diagnostic test performed on samples from the body (like blood, urine, or tissue).
- Device Description: The description focuses on physical design changes (shape, beads, handles, massage balls, collapsible feature) that relate to a physical therapy or massage device. There is no mention of analyzing biological samples.
- Lack of IVD Indicators: There is no mention of:
- Analyzing biological samples.
- Detecting or measuring substances in the body.
- Providing information for diagnosis, monitoring, or screening based on in vitro analysis.
- Image processing, AI/ML, or input imaging modality, which are often associated with certain types of IVDs (though not exclusively).
The device described is clearly intended for physical manipulation and therapy, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
"...used in the treatment and management of muscle spasm and muscle tension."
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
"The modifications of design change of "S" shape, adding roller beads and handles, adding interchangeable massage balls and adding a collapsible feature..."
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
"...physical therapy patient." and "OTC"
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): 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.
Thera-Cane K903820
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
NOV 26 1996
Image /page/0/Picture/2 description: The image shows a title section that reads "SECTION 14 SMDA SUMMARY for Safety and Effectiveness". The text is in a bold, sans-serif font and is centered on the page. The background is a light gray color.
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the written requirements of SMDA 1990 and 21 CFR 807.92
SAFETY AND EFFECTIVENESS OF THE MUSCLE WANDEM
These proposed changes to an already approved and marketed device does in no way alter the safety and effectiveness of this medical device. The Thera-Cane K903820 predicate device has a proven track record that establishes this product line as safe to the physical therapy patient. The modifications of design change of "S" shape, adding roller beads and handles, adding interchangeable massage balls and adding a collapsible feature does not change the safety or effectiveness of this device.
The proposed product is identical in intended use, materials, anatomical sites, target population, physical safety, biocompatibility and performance to the predicate device stated. Any modification made to the proposed device does not alter safety or effectiveness.
OTC Determination for this type of device has been proven safe to the consumer. The predicate device has been sold OTC since 1990 and has been proven to be an asset to the patient experiencing muscle spasm and/or muscle tension.
No claims are made implying cure. This device is used in the treatment and management of muscle spasm and muscle tension.
Seuah Maxwell Luke
Sarah Maxwell Lake, Shippert Medical Technologies Corporation
September 9, 1996
Date
filename: 510KWAND.doc