Identity
- Trade Name
- Dynatron Soundhead ` FDA UDI
- Generic Name
- Physical therapy ultrasound system applicator, hand-held FDA UDI
- Model / Reference
- WSH10 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10660584000291 FDA UDI
- 510(k) Number
- K031329 FDA UDI
- FDA Product Code
- IMI FDA UDI
- GMDN Term
- Physical therapy ultrasound system applicator, hand-held FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5300 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Area/Surface Area — 10.0 Square centimeter FDA UDI
Category: Physical therapy ultrasound system applicator, hand-held
Dynatron Soundhead ` by Dynatronics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K031329 also covers:
- Dynatron 25 Series 525B — Dynatronics Corp.
- Dynatron 25 Series 625B — Dynatronics Corp.
- Dynatron 25 Series 825B — Dynatronics Corp.
- Dynatron 25 Series 925B — Dynatronics Corp.
- Dynatron Solaris Plus 705 — Dynatronics Corp.
- Dynatron Solaris Plus 706 — Dynatronics Corp.
- Dynatron Solaris Plus 708 — Dynatronics Corp.
- Dynatron Solaris Plus 709 — Dynatronics Corp.
- Dynatron Solaris Plus 709 — Dynatronics Corp.
- Dynatron Soundhead — Dynatronics Corp.
- Dynatron Soundhead — Dynatronics Corp.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Dynatronics Corp.
Sources (1)
- FDA UDI 40f73d1f-7ab0-4bb8-b932-f401b2fb9140 36 fields · synced May 30, 2026