Description
This guidance document provides recommendations for 510(k) submissions for ultrasonic diathermy devices, also known as physiotherapy devices. Ultrasonic diathermy devices are devices under section 201(h) of the Federal Food, Drug and Cosmetic Act (the FD&C Act). This guidance includes recommendations on the use of certain International Electrotechnical Commission (IEC) standards in generating information that can support 510(k) submissions for these devices. This guidance also supplements other FDA documents regarding the specific content requirements and recommendations of a premarket notification (510(k)) submission (also refer to 21 CFR 807.87).
Scope & Applicability
Product Classes
4Guidance provides recommendations for 510(k) submissions for these physiotherapy devices.; Subject of the guidance document
Equipment for the generation and application of ultrasound to a patient for therapeutic purposes
regulated under 21 CFR 890.5300(a), product codes IMI and PFW, which are class II devices
Excluded from the scope of this guidance
Stakeholders
1individuals authorized to administer the device safely
Regulatory Context
Attributes
5Level of documentation required based on risk; higher documentation threshold for software functions; Risk-based documentation category requiring more detail; Outcome for software functions where failure presents a probable risk of death or serious injury; Outcome for devices where software failure presents a probable risk of death or serious injury.
Quotient of the active area gradient and the beam cross-sectional area
Ratio of the pulse duration to the pulse repetition period
Technical characteristic for labeling
Previous risk classification for ultrasonic diathermy devices under superseded guidance.; FDA's classification of software for ultrasonic diathermy devices
Identified Hazards
Hazards
2Risk to medical electrical equipment operation
information required in labeling for safe use
Related CFR Sections (5)
- 21CFR801.109§ 801.109 Prescription devices.
A device which, because of any potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use is not safe except under the supervision of a practitioner licensed by law to direct the use of such device, and hence for which “adequate directions for use” canRead full regulation →
- 21CFR801.5§ 801.5 Medical devices; adequate directions for use.
Adequate directions for use means directions under which the layman can use a device safely and for the purposes for which it is intended. Section 801.4 defines intended use. Directions for use may be inadequate because, among other reasons, of omission, in whole or in part, or incorrect specificatiRead full regulation →
- 21CFR807.87§ 807.87 Information required in a premarket notification submission.
Each premarket notification submission shall contain the following information:Read full regulation →
- 21CFR890.5300§ 890.5300 Ultrasonic diathermy.
(a) Ultrasonic diathermy for use in applying therapeutic deep heat for selected medical conditions —Read full regulation →
- 21CFR892.1570§ 892.1570 Diagnostic ultrasonic transducer.
(a) Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of dRead full regulation →
Related Warning Letters (10)
- 2025-12-09
CGMP/QSR/Medical Devices/Adulterated
Envoy Medical Inc.
- 2025-11-25
CGMP/QSR/Medical Devices/Adulterated
Hong Qiangxing Shenzhen Electronics Limited
- 2025-08-12
CGMP/QSR/Medical Devices/Adulterated
Spectra Therapy, LLC
- 2025-08-05
CGMP/QSR/Medical Devices/Adulterated
Mectronic Medicale S.R.L.
- 2025-06-24
CGMP/QSR/Medical Devices/Adulterated
Aju Pharm Co., Ltd.
- 2025-05-27
CGMP/QSR/Medical Devices/Adulterated
Sedecal S.A.
- 2025-05-20
CGMP/QSR/Medical Devices/Adulterated
NeuroSync, Inc.
- 2025-04-22
Noah Medical Corporation
- 2025-04-08
CGMP/QSR/Medical Devices/Adulterated
EpiCare Acquisitions, LLC
- 2025-03-25
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device
Exer Labs, Inc.
See Also (8)
- Presenting Risk Information in Prescription Drug and Medical Device Promotion (Status: Draft)
- Internet/Social Media Platforms with Character Space Limitations— Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices (Status: Draft)
- Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Arthroscopy Pump Tubing Sets Intended for Multiple Patient Use - Premarket Notification (510(k)) Submissions: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers (Status: Draft)
- CPG Sec. 396.400 Policy on Warned on Sunlamp Products (Status: Final)
- CPG Sec. 300.300 Ineffective Devices - 502(f)(I) Labeling Requirements (Status: Final)
- Policy on Warning Label Required on Sunlamp Products (Status: Final)