← Product Code LXM · K082218 # MAX ADJUSTING INSTRUMENT (K082218) _Manna Omni International, Inc. · LXM · Aug 13, 2008 · PM · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K082218 ## Device Facts - **Applicant:** Manna Omni International, Inc. - **Product Code:** LXM - **Decision Date:** Aug 13, 2008 - **Decision:** SESE - **Submission Type:** Traditional - **Device Class:** Class U - **Review Panel:** PM - **Attributes:** Therapeutic ## 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. ## Device Story Hand-held chiropractic adjusting instrument; replaces manual thrust with automatic, battery-powered electromechanical thrust. Device uses lithium-ion battery to power solenoid-driven plunger mechanism. Operated by licensed healthcare professionals in clinical settings. User selects single or multiple thrust modes via manual switch; four force settings available (75N, 125N, 175N, 250N). Device delivers mechanical force to spine or extremities to facilitate chiropractic adjustment. Benefits include consistent, automated force delivery compared to manual techniques. ## Clinical Evidence Bench testing only. Mechanical testing verified the device delivers four specific force settings: 75N, 125N, 175N, and 250N. Safety and performance testing was conducted on the lithium-ion rechargeable battery system. ## Technological Characteristics Hand-held electromechanical chiropractic instrument. Energy source: lithium-ion rechargeable battery. Actuation: solenoid-driven plunger. Force settings: 75N, 125N, 175N, 250N. Modes: single or multiple thrust. Operation: manual trigger/switch. No software or connectivity described. ## Predicate Devices - Impulse iQ Adjusting Instrument ([K080261](/device/K080261.md)) - Activator V Spinal Adjusting Instrument ([K072519](/device/K072519.md)) - Harrison Hand Held Adjusting Instrument ([K010851](/device/K010851.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {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 --- **Source:** [https://fda.innolitics.com/device/K082218](https://fda.innolitics.com/device/K082218) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com