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Solaris Soundhead

FDA UDI

Class II (US FDA UDI)

by Dynatronics Corp.

Identity

Trade Name
Solaris Soundhead FDA UDI
Generic Name
Physical therapy ultrasound system applicator, hand-held FDA UDI
Model / Reference
9GSH10 FDA UDI

Identifiers

Primary DI / UDI-DI
10660584000208 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
Not 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 Square centimeter FDA UDI

Solaris Soundhead by Dynatronics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K031329 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Dynatronics Corp.

Sources (1)

  • FDA UDI 0f234f84-b8f5-4f45-9c94-7ab6a0d1aa2b 37 fields · synced May 30, 2026