(106 days)
Not Found
No
The device description and intended use focus on physical support and compression, with no mention of AI/ML technologies or data processing.
Yes
The device is described as providing "relief of minor physical discomforts" and "compresses, supports and protects vulnerable body parts from post-injury impact," which are therapeutic actions.
No
The device description indicates it is an elasticized fitment for support and compression for relief of discomfort and protection from impact, not for identifying or diagnosing a condition.
No
The device description explicitly lists physical components such as "Elasticized fitment," "Anatomically contoured fabric," "Absortek fiber," and a "magnetic panel encased in fabric," indicating it is a physical medical 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 describes a device for providing physical support, compression, and protection to injured body parts. This is a physical therapy/supportive function, not a diagnostic test performed on samples taken from the body.
- Device Description: The device description details physical components like elasticized fabric, anatomical contouring, moisture-wicking material, anti-bacterial treatment, and a magnetic panel. These are all external physical components, not reagents, instruments, or software used to analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a disease or condition based on laboratory testing.
Therefore, this device falls under the category of a physical support or compression device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
For relief of minor physical discomforts occurring by acute trauma, repetitive stress and overuse injuries associated with first degree sprains of overstretched ligaments and first degree strain injuries to tendons. The device compresses, supports and protects vulnerable body parts from post-injury impact incurred by repetitive stress and overexertion self-limiting physical injuries.
Product codes (comma separated list FDA assigned to the subject device)
FQM, IOD, ILT
Device Description
(a) Elasticized fitment to support and compress an injured part of the body. (b) Anatomically contoured for adjustable fit and firmness for personal comfort and control of slippage and bunching of fabric. (c) Absortek fiber absorbs perspiration and transfers heat and moisture away from skin (d) Fabric treated with agent to resist growth of odor-causing bacteria and mildew (e) Non-intrusive magnetic panel encased in fabric.
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): 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.
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
§ 880.5075 Elastic bandage.
(a)
Identification. An elastic bandage is a device consisting of either a long flat strip or a tube of elasticized material that is used to support and compress a part of a patient's body.(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 § 880.9. The device also is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.
0
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 4 - 2004
Mr. Theodore Barash Theodore Barash 16879 C Isle of Palms Drive Delray Beach, Florida 33484
Re: K040054
Trade/Device Name: "Back in Action" Compression & Support with Anti-Bacterial Agent and Magnet Regulation Number: 880.5075 Regulation Name: Elastic Bandage Regulatory Class: II Product Code: FQM Dated: April 6, 2004 Received: April 7, 2004
Dear Mr. Barash:
This letter corrects our substantially equivalent letter of April 6, 2004 regarding the product code.
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 ({{or 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 (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 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.
1
Mr. Barash
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.
This letter will allow you to continue 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 and additionally Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at their toll free number (800) 638-2041 or at (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Kofoos4
APR 2 7 2004
Section G 510(k) Summary
| Submitters Name | Theodore Barash |
|---|---|
| Corporate Name Cleared | TheraGen International, Inc. |
| Address: | 16879 C Isle of Palms Dr. Delray Beach, Florida 33484 |
| Ph. | 561-498-8926 |
| Fax | 561-498-3902 |
| tedbarash@aol.com | |
| Written by | Theodore Barash |
| 561-498-8926 | |
| Date of Revised Summary | April 23, 2004 |
| Trade Name: | "Back in Action" Compression and Support with Anti-Bacterial Agent and Magnet |
Common Names and Classifications ..........
Elastic Bandage Product Code FQM Predicate 510(k) Number: K013244 Predicate Name: ComfortCare Compression and Support with Anti-Bacterial and Magnet
- Device Description - (a) Elasticized fitment to support and compress an injured part of the body. (b) Anatomically contoured for adjustable fit and firmness for personal comfort and control of slippage and bunching of fabric. (c) Absortek fiber absorbs perspiration and transfers heat and moisture away from skin (d) Fabric treated with agent to resist growth of odor-causing bacteria and mildew (e) Non-intrusive magnetic panel encased in fabric.
2. Intended Use
For relief of minor physical discomforts occurring by acute trauma, repetitive stress and overuse injuries associated with first degree sprains of overstretched ligaments and first degree strain injuries to tendons. The device compresses, supports and protects vulnerable body parts from post-injury impact incurred by repetitive stress and overexertion self-limiting physical injuries.
3
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Section G 510(k) Summary (continued)
Technological Character -- As indicated in the comparative table in Section E of paragraph 10 on page 10 - the properties of "Back in Action" devices demonstrate the same technological characteristics in design as an clastic bandage, woven fabric, fiber, finish, composition, anti-microbial agent, application, compression/support function, layered absorption/venting mechanisms, magnets and Indications for Use - as granted to ComfortCare products under K 013244, and cleared for marketing in December 07, 2001.
Summary - In addition to claiming substantial equivalence to a predicate under Part 880 Sub Part F -General Hospital and Personal Use Device, Product Code FQM, Regulation # 880.5075 - "Back in Action" products would also qualify for SE under --
Part 890 Subpart F - Physical Medicine Therapeutic Devices, Product Code IOD, Regulation # 890.5350 Exercise Component as "Adjunct to Restore Motion"
Part 890 Sub Part F - Physical Medicine Therapeutic Device, Product Code ILT, Regulation # 890.5050 Daily Activity Assist Device to "Perform an Exercise Function"
-
- Products similar to "Back in Action"Compression and Support with Anti-Bacterial and Magnets are in broad common use in the USA and throughout the world.
-
- Its characteristics and properties are substantially equivalent to a cleared predicate of 'compression and support products' as identified above.
-
- There are no material modifications that affect or change the fundamental technology and science for a similar legally marketed device.
-
- The primary copy emphasis of each product's packaging is on multi-tasking attributes of compression, support, perspiration control and anti-microbial protection.
We believe that "Back in Action" products meet the standards for 'substantial equivalence' and merit market clearance by the agency on several levels of application and usage as indicated.
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K 040054
Indications for Use
510(k) Number : K040054 Device Name: "BACK IN ACTION" COMPRESSION & SUPPORT WITH ANTI-BACTERIAL AGENT and MAGNET
Indications For Use:
For relief of minor physical discomforts incurred by acute trauma, repetitive stress and overuse injuries associated with first degree sprains of overstretched ligaments and first degree strain injuries to tendons. The device compresses, supports and protects vulnerable body parts from post-injury impact incurred by repetitive stress and overexertion self-limiting physical injuries.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use X (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON OTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODF)
Arthur 29, 2023
Page 1 of 1
n of Anesthesiology, General Hospital, Infection Control, Dental Device
510(k) Number: