Regulatory & Compliance
At Med-Pat Solutions, regulatory compliance, product safety, and transparency are core to how we source and sell our products. We offer both FDA-regulated medical devices and non-medical communication equipment, each governed by different regulatory frameworks.
Important clarity: FDA 510(k) clearance and FDA establishment registration are different things. 510(k) clearance is device-level; establishment registration identifies a manufacturing facility and does not independently constitute FDA approval of a device.
Compliance Summary Table
This table lists only the products we sell and the compliance frameworks that apply to each category.
| Product | Category | FDA Device Class & CFR | FDA Product Code | 510(k) | OEM FDA Establishment Reg. | Third-Party Testing | Telecom / Electrical (Non-medical) |
|---|---|---|---|---|---|---|---|
| PX-1 Pulse Oximeter | Medical device |
Class II 21 CFR § 870.2700 |
DQA | K232989 | 3009551875 (AOJ Medical) | TÜV SÜD Q5 103703004 Rev. 01 | Not applicable |
| PXC-1 Pediatric Pulse Oximeter | Medical device |
Class II 21 CFR § 870.2700 |
DQA | K232989 | 3009551875 (AOJ Medical) | TÜV SÜD Q5 103703004 Rev. 01 | Not applicable |
| TH-1 Infrared Thermometer | Medical device |
Class II 21 CFR § 880.2910 |
FLL | K221039 | 3009551875 (AOJ Medical) | TÜV SÜD Q5 103703004 Rev. 01 | Not applicable |
| BP-R Arm Blood Pressure Monitor | Medical device |
Class II 21 CFR § 870.1130 |
DXN | K244000 | 3009551875 (AOJ Medical) | TÜV SÜD Q5 103703004 Rev. 01 | Not applicable |
| BP-S Arm Blood Pressure Monitor | Medical device |
Class II 21 CFR § 870.1130 |
DXN | K244000 | 3009551875 (AOJ Medical) | TÜV SÜD Q5 103703004 Rev. 01 | Not applicable |
| Telephones & Emergency Auto-Dialers | Non-medical | Not FDA-regulated | N/A | N/A | N/A | Intertek 9700392 (where applicable) |
FCC ID: LCSA01124021E ANSI / UL: 1459 Applies to applicable models/configurations tested under these identifiers. |
FDA-Regulated Medical Devices
The following Med-Pat Solutions products are regulated by the U.S. Food & Drug Administration (FDA) as medical devices: PX-1, PXC-1, TH-1, BP-R, and BP-S.
Pulse Oximeters: PX-1 & PXC-1
- Classification Name: Oximeter
- Product Code: DQA
- Device Class: Class II
- Regulation: 21 CFR § 870.2700
- 510(k): K232989
Infrared Thermometer: TH-1
- Classification Name: Continuous Measurement Thermometer
- Product Code: FLL
- Device Class: Class II
- Regulation: 21 CFR § 880.2910
- 510(k): K221039
Blood Pressure Monitors: BP-R & BP-S
- Classification Name: System, Measurement, Blood-Pressure, Non-Invasive
- Product Code: DXN
- Device Class: Class II
- Regulation: 21 CFR § 870.1130
- 510(k): K244000
FDA wording note: “FDA cleared” refers to 510(k) clearance (substantial equivalence to a legally marketed predicate device). It does not mean FDA endorsement or “FDA approved.”
FDA-Registered Manufacturer (OEM)
Med-Pat Solutions medical devices are manufactured by an FDA-registered establishment:
- Manufacturer: Shenzhen AOJ Medical Technology Co., Ltd.
- FDA Establishment Registration Number: 3009551875
- Owner / Operator Number: 10059056
- Establishment Operation: Manufacturer
FDA establishment registration identifies a manufacturing facility and does not independently constitute FDA approval of individual devices.
Third-Party Medical Device Testing (TÜV SÜD)
Certain Med-Pat Solutions medical devices have been independently evaluated by TÜV SÜD, a globally recognized testing and certification organization.
- TÜV SÜD Certificate: Q5 103703004 Rev. 01
- Applicable Med-Pat Products: BP-R, BP-S, TH-1, PX-1, PXC-1
TÜV SÜD certification represents third-party assessment of applicable safety and performance standards at the time of testing and does not replace or imply FDA approval or clearance.
Non-Medical Products
Med-Pat Solutions also offers telephones and emergency communication devices (including auto-dialers). These are non-medical products and are not regulated by the FDA. They fall under telecommunications and electrical safety requirements.
FCC Compliance
- FCC Identifier: LCSA01124021E
FCC compliance applies to applicable models/configurations tested under the listed FCC ID.
Electrical Safety Standards (ANSI / UL)
- ANSI / UL Standard: 1459 (Telephone Equipment)
Independent Safety Certification (Intertek)
- Intertek Certification Number: 9700392
Intertek certification applies to applicable models/configurations covered under the listed certification number.
Scope Clarification
- FDA regulations apply only to the Med-Pat medical devices listed on this page.
- FCC, ANSI/UL, and Intertek certifications apply only to applicable non-medical communication products.
- Regulatory status varies by product and intended use.
Intended Use & Medical Disclaimer
Med-Pat Solutions medical devices are intended to support monitoring and general wellness where applicable and are not a substitute for professional medical advice. Users should consult qualified healthcare professionals for diagnosis and treatment.
Contact & Regulatory Inquiries
Med-Pat Solutions
31 Riordan Place, Shrewsbury, NJ 07734
Phone: 800-626-0410
Website: www.medpatsolutions.com
Compliance documentation may be provided upon request for institutional, distributor, or regulatory review.