Doctor Tecar Plus, Doctor Tecar Smart

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K221043 ↗

FDA Product Code

PBX

Device Class

Class II

Regulation

21 CFR Part 878.4400

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• What clinical settings are the Doctor Tecar Plus and Doctor Tecar Smart primarily used in, and why are they suitable for those environments?

  The Doctor Tecar Plus and Doctor Tecar Smart are designed for clinical use in general and plastic surgery settings. They are categorized as massagers with vacuum and radiofrequency-induced heat, which deliver energy transfer to stimulate biological tissues and promote natural repair and recovery processes. This makes them particularly useful in surgical environments where tissue regeneration and recovery are key concerns.

• Are the Doctor Tecar Plus and Doctor Tecar Smart devices reusable, and what storage conditions should be followed?

  Yes, the Doctor Tecar Plus and Doctor Tecar Smart are reusable devices. To maintain their functionality and hygiene, they must be stored in a clean, dry environment. Proper storage ensures longevity and prevents contamination, which is critical for clinical use.

• Can these devices be used in an MRI environment, and if not, what precautions should be taken?

  No, the Doctor Tecar Plus and Doctor Tecar Smart are explicitly stated as not MRI-safe. This means they should never be used in or near an MRI machine, as the electromagnetic fields generated by MRI scanners could interfere with the device or pose safety risks to patients. Always ensure the device is removed from the MRI environment and stored separately.

• What regulatory pathway was followed for FDA clearance of the Doctor Tecar Plus and Doctor Tecar Smart, and what does this mean for clinicians?

  The Doctor Tecar Plus and Doctor Tecar Smart received FDA clearance through a 510(k) submission (K221043), classified under product code PBX and device class 2. This means the manufacturer demonstrated that the devices are substantially equivalent to legally marketed predecessors, ensuring they meet FDA safety and effectiveness standards for their intended use. Clinicians can rely on this clearance as evidence of regulatory review for their clinical applications in general and plastic surgery.

• How many different models or configurations of the Doctor Tecar Plus and Doctor Tecar Smart are available, and what does this imply for customization?

  While the provided data lists multiple FEI numbers (e.g., 3030420005, 3002808227), these are internal FDA registration identifiers rather than distinct clinical models. The core devices—Doctor Tecar Plus and Doctor Tecar Smart—share the same fundamental design (radiofrequency-induced heat massagers with vacuum capabilities) but may differ in software, accessories, or connectivity features. Clinicians should confirm specific model variations (e.g., Smart vs. Plus) with the manufacturer for tailored applications in tissue stimulation or recovery protocols.