(7 days)
Not Found
No
The description focuses on the electromechanical nature of the device and its force settings, with no mention of AI or ML terms or functionalities.
Yes
The device is indicated for chiropractic adjustment of the spine and/or extremities, which is a therapeutic intervention.
No
The device is used for chiropractic adjustments, which is a treatment, not for diagnosing conditions.
No
The device description clearly states it is a "hand-held chiropractic adjusting instrument" that is "electromechanical" and uses a "plunger-like mechanism," indicating it is a physical hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states that MAX is a hand-held chiropractic adjusting instrument used for external application to the spine and/or extremities. It delivers mechanical thrusts for chiropractic adjustments.
- Lack of Specimen Analysis: There is no mention of collecting or analyzing any biological specimens from the patient.
Therefore, MAX falls under the category of a therapeutic or physical medicine device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
MAX is indicated for chiropractic adjustment of the spine and/or extremities. MAX should be used by a licensed health care professional only. Intended for external use only.
Product codes (comma separated list FDA assigned to the subject device)
LXM
Device Description
MAX is a hand-held chiropractic adjusting instrument that features automatic battery-powered operation instead of manual thrust. The electromechanical instrument uses a plunger-like mechanism to deliver thrust for chiropractic adjustment. The instrument is intended for use by a health care professional licensed by the law of the state in which he or she practices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
spine and/or extremities
Indicated Patient Age Range
Not Found
Intended User / Care Setting
licensed health care professional
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)
MAX has four force settings that have been mechanically tested to deliver 75N, 125N, 175N, or 250N per thrust. The lithium-ion rechargeable battery has been tested for safety and performance.
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.
K080261 Impulse iQ Adjusting Instrument, K072519 Activator V Spinal Adjusting Instrument, K010851 Harrison Hand Held Adjusting Instrument
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
N/A
0
KOS 2218 fage 1
Manna Omni International, Inc.
5. 510(K) SUMMARY
AUG 1 3 2008
Canna Omni International, Inc.
This summary was prepared on the 25th day of June in the year 2008 per 21 CFR 807.92. This 510(k) submission is for the MAX Adjusting Instrument owned by Manna Omni International, Inc., which is located at 340 E. Commonwealth Avenue in Fullerton, CA 92832. The submitter and primary contact is Stephen Tsai, who can be contacted by phone at 714-871-7118 or fax at 714-871-3372. The device is submitted for regulation under product code LXM of unclassified devices that are plunger-like joint manipulators and reviewed by the physical medicine panel.
| (a)(2) | Device trade name | MAX Adjusting Instrument |
|---|---|---|
| Common name | Chiropractic adjusting instrument | |
| Classification name | Manipulator, plunger-like joint | |
| (a)(3) | Legally marketed devices | |
| for substantial equivalence | K080261 Impulse iQ Adjusting Instrument | |
| K072519 Activator V Spinal Adjusting Instrument | ||
| K010851 Harrison Hand Held Adjusting Instrument | ||
| (a)(4) | Device description | MAX is a hand-held chiropractic adjusting instrument that features |
| automatic battery-powered operation instead of manual thrust. The | ||
| electromechanical instrument uses a plunger-like mechanism to | ||
| deliver thrust for chiropractic adjustment. The instrument is intended | ||
| for use by a health care professional licensed by the law of the state in | ||
| which he or she practices. | ||
| (a)(5) | Intended Use | MAX is indicated for chiropractic adjustment of the spine and/or |
| extremities. MAX should be used by a licensed health care | ||
| professional only. Intended for external use only. | ||
| (a)(6) | Technological Characteristics | The MAX adjusting device delivers an automatic thrust from the push |
| of a trigger by using a lithium ion rechargeable battery to power a | ||
| solenoid. The energy source is a lithium-ion rechargeable battery. A | ||
| manual switch allows the user to select single thrust or multiple thrust | ||
| modes. The instrument has four force settings. | ||
| (b)(1) | Performance Data | MAX has four force settings that have been mechanically tested to |
| deliver 75N, 125N, 175N, or 250N per thrust. The lithium-ion | ||
| rechargeable battery has been tested for safety and performance. | ||
| (b)(3) | Conclusion | MAX is substantially equivalent to predicate devices in terms of safety, |
| effectiveness, and performance. It uses a plunger-like mechanism for | ||
| chiropractic adjustment of the spine and extremities and is intended for | ||
| external use only. The device is only used by licensed health care | ||
| professionals. MAX delivers a similar force range to predicate devices | ||
| but uses a rechargeable battery to power the push-button, automatic | ||
| thrust. |
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 3 2008
Manna Omni International, Inc. % Stephen Tsai, M.D. President 340 East Commonwealth Avenue Fullerton, California 92832
Re: K082218
Trade/Device Name: MAX Adjusting Instrument Regulatory Class: Unclassified Product Code: LXM Dated: August 4, 2008 Received: August 6, 2008
Dear Dr. Tsai:
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. Iisting 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 such 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.
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 begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally
2
Page 2 -Stephen Tsai, M.D.
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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark M. Millman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Manna Omni International, Inc.
4. INDICATIONS FOR USE STATEMENT
Indications for Use MAX Adjusting Instrument
MAX is indicated for chiropractic adjustment of the spine and/or extremities. MAX should be used by a licensed health care professional only. Intended for external use only.
X 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)
Page 1 of 1
Bulhar Brichu for men
(Division Sign-Off)
eral, Restorative. and Neurological Devices
510(k) Number K082218