Uterine ElevatOR PRO with OccludOR Balloon

K220202 · The O R Company Pty, Ltd. · LKF · Mar 31, 2022 · Obstetrics/Gynecology

Device Facts

• Record ID: K220202
• Device Name: Uterine ElevatOR PRO with OccludOR Balloon
• Applicant: The O R Company Pty, Ltd.
• Product Code: LKF · Obstetrics/Gynecology
• Decision Date: Mar 31, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.4530
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Uterine ElevatOR PRO with OccludOR Balloon™ is indicated for manipulation of the uterus, and injection of fluids or gases during laparoscopic procedures including total laparoscopic hysterectomy, laparoscopic assisted vaginal hysterectomy, laparoscopic tubal occlusion, and diagnostic laparoscopy. The Uterine ElevatOR PRO with OccludOR Balloon™ maintains pneumoperioneum during laparoscopic procedures by sealing the vagina once colpotomy is performed.

Device Story

Sterile, single-use uterine manipulator/injector for laparoscopic surgery. Device features stainless steel shaft, intrauterine balloon, cervical cup, and vaginal cup. Surgeon inserts device into uterus; inflates intrauterine balloon via syringe to secure position; adjusts vaginal cup along shaft to seal vagina. OccludOR balloon provides additional seal to maintain pneumoperitoneum during colpotomy. Port at handle allows injection of fluids/gases. Used in OR by gynecological surgeons. Output is mechanical manipulation of uterus and maintenance of surgical field pressure. Benefits include improved uterine positioning and reduced gas leakage during procedures.

Clinical Evidence

Bench testing only. No clinical data provided. Biocompatibility testing performed per ISO 10993-1, -5, -10, -11 and USP <151>. Mechanical testing included balloon integrity, burst, fatigue, and adhesion tests; vaginal/cervical cup leakage and strength tests; and handle/joint strength tests. All tests met pre-specified acceptance criteria.

Technological Characteristics

Sterile, single-use, manual instrument. Materials: stainless steel shaft, PVC balloons. Features: intrauterine balloon (7-10cc), cervical cup (32-40mm), vaginal cup, locking assembly, dye injection port. Energy: manual. Sterilization: Ethylene Oxide. No software or electronic components.

Indications for Use

Indicated for patients undergoing laparoscopic procedures including total laparoscopic hysterectomy, laparoscopic assisted vaginal hysterectomy, laparoscopic tubal occlusion, and diagnostic laparoscopy requiring uterine manipulation, fluid/gas injection, and maintenance of pneumoperitoneum.

Regulatory Classification

Identification

An obstetric-gynecologic specialized manual instrument is one of a group of devices used during obstetric-gynecologic procedures to perform manipulative diagnostic and surgical functions (e.g., dilating, grasping, measuring, and scraping), where structural integrity is the chief criterion of device performance. This type of device consists of the following:(1) An amniotome is an instrument used to rupture the fetal membranes. (2) A circumcision clamp is an instrument used to compress the foreskin of the penis during circumcision of a male infant. (3) An umbilical clamp is an instrument used to compress the umbilical cord. (4) A uterine curette is an instrument used to scrape and remove material from the uterus. (5) A fixed-size cervical dilator is any of a series of bougies of various sizes used to dilate the cervical os by stretching the cervix. (6) A uterine elevator is an instrument inserted into the uterus used to lift and manipulate the uterus. (7) A gynecological surgical forceps is an instrument with two blades and handles used to pull, grasp, or compress during gynecological examination. (8) A cervical cone knife is a cutting instrument used to excise and remove tissue from the cervix. (9) A gynecological cerclage needle is a looplike instrument used to suture the cervix. (10) A hook-type contraceptive intrauterine device (IUD) remover is an instrument used to remove an IUD from the uterus. (11) A gynecological fibroid screw is an instrument used to hold onto a fibroid. (12) A uterine sound is an instrument used to determine the depth of the uterus by inserting it into the uterine cavity. (13) A cytological cervical spatula is a blunt instrument used to scrape and remove cytological material from the surface of the cervix or vagina. (14) A gynecological biopsy forceps is an instrument with two blades and handles used for gynecological biopsy procedures. (15) A uterine tenaculum is a hooklike instrument used to seize and hold the cervix or fundus. (16) An internal pelvimeter is an instrument used within the vagina to measure the diameter and capacity of the pelvis. (17) A nonmetal vaginal speculum is a nonmetal instrument used to expose the interior of the vagina. (18) A fiberoptic nonmetal vaginal speculum is a nonmetal instrument, with fiberoptic light, used to expose and illuminate the interior of the vagina.

Special Controls

*Classification.* (1) Class II (special controls). The device, when it is an umbilical clamp with or without a cutter, a uterine tenaculum which is sterile and does not use suction and is intended for single use, a nonmetal vaginal speculum, or a fiberoptic nonmetal vaginal speculum, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.(2) Class I for the amniotome, uterine curette, cervical dilator (fixed-size bougies), cerclage needle, IUD remover, uterine sound, and gynecological biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.

Predicate Devices

• VCARE (Vaginal-Cervical Ahluwalia's Retractor-Elevator) (K142716)

Reference Devices

• Koh Colpotomizer System (K954311)

Submission Summary (Full Text)

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March 31, 2022

The O R Company Pty Ltd Nicole Conway Quality Assurance & Regulatory Affairs Manager 1/32 Silkwood Rise Carrum Downs, Victoria 3201 Australia

Re: K220202

> Trade/Device Name: Uterine ElevatOR PRO with OccludOR Balloon™ Regulation Number: 21 CFR§ 884.4530 Regulation Name: Obstetric-Gynecologic Specialized Manual Instrument Regulatory Class: II Product Code: LKF Dated: January 28, 2022 Received: February 3, 2022

Dear Nicole Conway:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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.

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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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Jason R. Roberts, Ph.D. Assistant Director DHT3B: Division of Reproductive. Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K220202

Device Name

Uterine ElevatOR PRO with OccludOR Balloon TM

Indications for Use (Describe)

The Uterine ElevatOR PRO with OccludOR Balloon™ is indicated for manipulation of the uterus, and injection of fluids or gases during laparoscopic procedures including total laparoscopic hysterectomy, laparoscopic assisted vaginal hysterectorny, laparoscopic tubal occlusion, and diagnostic laparoscopy. The Uterine ElevatOR PRO with OccludOR Balloon™ maintains pneumoperioneum during laparoscopic procedures by sealing the vagina once colpotomy is performed.

Type of Use (Select one or both, as applicable)

| <span style="font-family: Arial;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) |
|-----------------------------------------------------------------------------------------|
| <span style="font-family: Arial;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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Image /page/3/Picture/2 description: The image shows the logo for Symmetry Surgical Company. The logo features a stylized red and gray shape to the left of the text. The text reads "symmetry surgical" in a gray sans-serif font, with the word "company" in a smaller font size to the right.

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# Uterine ElevatOR PRO with OccludOR Balloon™ - 510(k) Summary

#### l. SUBMITTER

The O R Company Pty Ltd 1/32 Silkwood Rise, Carrum Downs, VIC 3201, Australia Phone: [phone] Fax: + 61 3 9413 5556

Contact Person: Nicole Conway Email: [e-mail] Date Prepared: January 19, 2022

#### II. DEVICE

Trade Name: Uterine ElevatOR PRO with OccludOR Balloon™ Model numbers: UE-OBPRO-32, UE-OBPRO-35, UE-OBPRO-37 and UE-OBPRO-40 Common Name: Uterine Manipulator / Injector Regulation Number: 21 CFR 884.4530 Classification Name: Obstetric-Gynecologic Specialized Manual Instrument Regulatory Class: II Product Code: LKF

#### III. PREDICATE DEVICE

Conmed Corporation, VCARE (Vaginal-Cervical Ahluwalia's Retractor-Elevator), K142716

This predicate has not been subject to a design-related recall.

## Reference devices:

Coopersurgical, Inc., Koh Colpotomizer System, K954311

#### IV. DEVICE DESCRIPTION

The Uterine ElevatOR PRO with OccludOR Balloon™ is a sterile, single-use medical device used to manipulate the uterus and cervix in surgical and diagnostic procedures. The device includes an insulated and anatomically designed stainless steel shaft with an intrauterine balloon and reference graduations (centimetres) at the proximal [to patient] end and an external handle at the distal end. The intrauterine balloon is inflated with air using a standard syringe (not included). The device has a vaginal cup that is pushed along the shaft to support a green cervical cup. The cervical cup provides a guide for colpotomy. There are four sizes of cervical cups available, 32mm, 37mm, and 40mm, which correspond to the different model numbers. A locking assembly secures the position of the vaginal cup and therefore the cervical cup. Sites for suturing are located on the cervical cup. An Occluder Balloon further reduces

### Asia Pacific

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Image /page/4/Picture/0 description: The image shows the logo for Symmetry Surgical Company. The logo features the words "symmetry surgical" in a sans-serif font, with the word "company" in a smaller font size to the right. To the left of the text is a red and gray graphic element.

Image /page/4/Picture/2 description: The image shows the logo for "THE O.R. COMPANY". The letters "O.R." are inside of a blue circle. Below the company name is the tagline "The smart way to operate".

leakage of pneumoperitoneum during laparoscopic surgery. A port at the distal end of handle provides a channel for injection of fluids or gases.

#### V. INDICATIONS FOR USE

The Uterine ElevatOR PRO with OccludOR Balloon™ is indicated for manipulation of the uterus, and injection of fluids or gases during laparoscopic procedures including total laparoscopic hysterectomy, laparoscopic assisted vaginal hysterectomy, laparoscopic tubal occlusion, and diagnostic laparoscopy. The Uterine ElevatOR PRO with OccludOR Balloon™ maintains pneumoperitoneum during laparoscopic procedures by sealing the vagina once colpotomy is performed.

| Attributes | Uterine ElevatOR<br>PRO with<br>OccludOR Balloon<br>K220202 | VCARE® Vaginal-<br>Cervical-<br>Ahluwalia's-<br>Retractor-<br>Elevator K142716 | Discussion |
|----------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Manufacturer | The O R Company Pty<br>Ltd | CONMED<br>Corporation | --- |
| Class | II | II | Same |
| Regulation Number | 884.4530 | 884.4530 | Same |
| Regulation Generic Name | Cannula,<br>Manipulator/Injector,<br>Uterine | Cannula,<br>Manipulator/Injector,<br>Uterine | Same |
| Indications for Use | The Uterine ElevatOR<br>PRO with OccludOR<br>Balloon™is indicated<br>for manipulation of<br>the uterus, and<br>injection of fluids or<br>gasses during<br>laparoscopic<br>procedures including<br>total laparoscopic<br>hysterectomy,<br>laparoscopic assisted<br>vaginal<br>hysterectomy,<br>laparoscopic tubal<br>occlusion, and<br>diagnostic<br>laparoscopy. The<br>Uterine ElevatOR<br>PRO with OccludOR<br>Balloon™ maintains<br>pneumoperitoneum<br>during laparoscopic | The ConMed VCARE®<br>Retractor/Elevator is<br>indicated for<br>manipulation of the<br>uterus and injection<br>of fluids or gases<br>during laparoscopic<br>procedures such as<br>Laparoscopic<br>Assisted Vaginal<br>Hysterectomy<br>(LAVH), Total<br>Laparoscopic<br>Hysterectomy (TLH),<br>minilap, laparoscopic<br>tubal occlusion, or<br>diagnostic<br>laparoscopy and also<br>maintains<br>pneumoperitoneum<br>by sealing the vagina<br>once a colpotomy is<br>performed. | Same |
| | procedures by<br>sealing the vagina<br>once colpotomy is<br>performed. | | |
| Sterile | Yes, Ethylene Oxide | Yes, Ethylene Oxide | Same |
| Prescription Use | Yes | Yes | Same |
| Single Use | Yes | Yes | Same |
| Intrauterine Balloon inflation volume | 7 – 10 сс | 7 – 10 сс | Same |
| Intrauterine Balloon inflation method | The intrauterine<br>balloon is inflated by<br>passing air from a<br>syringe through a<br>pilot balloon located<br>at the distal end of<br>the device. Inflation<br>is maintained by a<br>one-way valve<br>positioned in the<br>pilot balloon. The<br>pilot balloon also<br>serves as an indicator<br>of intrauterine<br>balloon inflation. | The intrauterine<br>balloon is inflated by<br>passing air from a<br>syringe through a<br>pilot balloon located<br>at the distal end of<br>the device. Inflation<br>is maintained by a<br>one-way valve<br>positioned in the<br>pilot balloon. The<br>pilot balloon also<br>serves as an indicator<br>of intrauterine<br>balloon inflation. | Same |
| Occluder Balloon | Yes | No | Different |
| Mode of action | Mechanical device<br>positioning prior to<br>performing indicated<br>laparoscopic<br>procedures | Mechanical device<br>positioning prior to<br>performing indicated<br>laparoscopic<br>procedures | Same |
| Rigid, insulated and anatomically<br>curved shaft | Yes | Yes | Same |
| Handle at the distal [to patient] end | Yes | Yes | Same |
| Intrauterine balloon at proximal end<br>[to patient] end | Yes | Yes | Same |
| Intrauterine balloon material | PVC | PVC | Same |
| Device Components | Direct patient<br>contacting:<br>Plug cap<br>Intrauterine Balloon<br>Intrauterine Balloon<br>Colorant<br>Heat-shrink on the<br>shaft<br>Stopper on the shaft<br>Graduation marking<br>Cervical cup | Direct patient<br>contacting:<br>Intrauterine Balloon<br>Intrauterine Balloon<br>Colorant<br>Heat-shrink on the<br>shaft<br>Stopper on the shaft<br>Graduation marking<br>Cervical cup<br>Vaginal Cup | Similar |
| | OccludOR balloon<br>OccludOR balloon<br>inflation line<br>Non-contacting:<br>Shaft<br>Thumbscrew &<br>locking assembly<br>Thumbscrew &<br>locking assembly<br>colorant<br>Handle<br>Pilot balloon<br>Air inflation valve<br>Air Inflation line<br>Dye Injection port<br>Dye Injection port<br>cap<br>Robert Clamp<br>Inflation port for<br>OccludOR balloon | Non-contacting:<br>Shaft<br>Thumbscrew &<br>locking assembly<br>Thumbscrew &<br>locking assembly<br>colorant<br>Handle<br>Pilot balloon<br>Air inflation valve<br>Air Inflation line<br>Dye Injection port<br>Dye Injection port<br>cap | |
| Anatomical site | Mucosal<br>Membranes- Uterus<br>and Vagina | Mucosal<br>Membranes- Uterus<br>and Vagina | Same |
| Contact Period | Short-term contact<br>(≤24 hours) | Short-term contact<br>(≤24 hours) | Same |

#### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE VI.

### Asia Pacific

T [phone] F [phone]

North America

USA

3034 Owen Drive T [phone] Antioch TN, 37013 F [phone]

Contact

[e-mail] theorcompany.com

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Image /page/5/Picture/0 description: The image shows the logo for "THE O.R. COMPANY". The letters "O.R." are inside of a blue circle. Below the company name is the tagline "The smart way to operate".

Image /page/5/Picture/1 description: The image shows the logo for Asymmetry. The logo consists of the letter A followed by a stylized letter S. The letter S is split into two parts, with the top part being gray and the bottom part being red. The word "symmetry" is written in gray to the right of the letter S.

symmetry surgical" company

vie.

### Asia Pacific

T [phone]
F [phone]

North America

3034 Owen Drive
Antioch TN, 37013
USA

T [phone]
F+1 800-342-3272

Contact

[e-mail] theorcompany.com

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Image /page/6/Picture/0 description: The image is a logo for "THE O.R. COMPANY". The company name is in blue font, with the "O.R." in a blue circle. Below the company name is the tagline "The smart way to operate".

Image /page/6/Picture/1 description: The image shows the logo for Symmetry Surgical. The logo consists of the letter "A" followed by a stylized "S" made up of two curved shapes, one red and one gray. To the right of the logo is the text "symmetry surgical" in a gray sans-serif font.

Both the subject and predicate devices are sterile, single-use medical devices used to manipulate the uterus and cervix in surgical and diagnostic procedures. At a high level, the subject and predicate devices are based on the following same technological elements:

- An anatomically contoured shaft. ●
- An intrauterine balloon at the proximal [to patient] end, a handle at the distal end. ●
- A cervical cup and a vaginal cup.
- . A locking mechanism to secure the vaginal cup in position.
- An inflation line for the intrauterine balloon.
- A dye injection port at the distal end of the handle. ●

The following technological differences exist between the subject and predicate devices:

- The subject device includes the OccludOR Balloon, which is similar to a feature of ● the Colpo-Pneumo Occluder device cleared under K954311.
These differences do not raise different questions of safety and effectiveness as compared to the predicate.

### Asia Pacific

3201, Australia

1/32 Silkwood Rise T [phone]

USA

3034 Owen Drive T [phone] Antioch TN, 37013 F [phone] Contact

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Image /page/7/Picture/0 description: The image shows the logo for "THE O.R. COMPANY". The "O.R." is inside of a blue circle. Below the company name is the tagline "The smart way to operate".

#### VII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

## Biocompatibility testing

The biocompatibility evaluation for the subject device was conducted in accordance with the FDA guidance "Use of International Standard ISO 10993-1: 2018, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The subject device underwent the following tests:

- Cytotoxicity per ISO 10993-5:2009
- Irritation per ISO 10993-10:2010
- Sensitization per ISO 10993-5:2010
- Acute Systemic toxicity per ISO 10993-11:2017
- Pyrogenicity per ISO 10993-11 and USP <151>

The subject device is considered externally communicating device & surface contact device that may come in contact with tissue and breached or compromised surface respectively for a duration of less than 24 hours.

## Performance & mechanical testing

The following performance and mechanical tests demonstrated that the subject device performs substantially equivalent to the predicate device:

- Intrauterine balloon integrity & concentric inspection ●
- Intrauterine balloon inflation stability test for a defined time period.
- Intrauterine balloon burst test
- Intrauterine balloon fatigue test ●
- Intrauterine balloon adhesion strength test ●
- OccludOR balloon outer diameter inspection & leakage free test
- OccludOR balloon deflation time test
- OccludOR balloon capacity test- reliability/safety
- OccludOR balloon fatigue durability test
- OccludOR balloon burst test
- Vaginal cup air leakage test
- Cervical cup temperature test
- Air inflation valve test
- Dye-injection port compliance & leakage test
- Thumb screw strength test
- Locking force test of vaginal cup
- Ease of movement of vaginal cup along the shaft ●
- Cervical cup detachment force test
- Cervical cup stopper adhesion strength test ●

### Asia Pacific

North A

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Image /page/8/Picture/0 description: The image shows the logo for "The O.R. Company". The letters "O.R." are inside of a blue circle. Below the company name is the tagline "The smart way to operate".

symmetry surgical" company

- . Device tensile strength
- . Handle joint strength
- . Tip deflection
- Ultrasonic welding strength

In all testing, the subject device met the pre-specified acceptance criteria.

## Conclusion:

The intended use of the subject device is identical to the predicate device. The subject device has similar technological characteristics to the predicate device. The differences in technological characteristics between the subject and predicate devices do not raise different questions of safety and effectiveness. All testing undertaken to demonstrate substantial equivalence of the subject device meet the predetermined acceptance criteria. The test results demonstrate that the subject device is as safe and effective as the predicate device.

Asia Pacific

North America

3034 Owen Drive Antioch TN, 37013 USA

T [phone] F [phone] Contact

[e-mail] theorcompany.com