| Part B: Supplementary Information Sheet (SIS) |
|
FR Recognition List Number
|
062
|
Date of Entry 05/29/2024
|
|
FR Recognition Number
|
6-500
|
| Standard | |
IEC 63045 Edition 1.0 2020-05
Ultrasonics - Non-focusing short pressure pulse sources including ballistic pressure pulse sources - Characteristics of fields |
|
Scope/AbstractThis document is applicable to:
- therapy equipment using extracorporeally induced non-focused or weakly focused pressure pulses;
- therapy equipment producing extracorporeally induced non-focused or weakly focused mechanical energy,
where the pressure pulses are released as single events of duration up to 25 µs.
This document does not apply to:
- therapy equipment using focusing pressure pulse sources such as extracorporeal lithotripsy equipment;
- therapy equipment using other acoustic waveforms like physiotherapy equipment, low intensity ultrasound equipment and HIFU/HITU equipment.
This document specifies:
- measurable parameters which are used in the declaration of the acoustic output of extracorporeal equipment producing a non-focused or weakly focused pressure pulse field,
- methods of measurement and characterization of non-focused or weakly focused pressure pulse fields. |
|
| Extent of Recognition
|
Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| §890.5660 |
Massager, Therapeutic, Electric
|
Class 1
|
ISA
|
|
Relevant FDA Guidance and/or Supportive Publications*
Lohrer, H., Nauck T., "Shock Waves in Sports medicine", Level 10 Publisher, 2018.
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018. |
|
| FDA Technical Contact
|
| Standards Development Organization
|
FDA Specialty Task Group (STG)
| General Plastic Surgery/General Hospital |
|
| *These are provided as examples and others may be applicable. |
