Identity
- Trade Name
- AUTOSOUND FDA UDI
- Generic Name
- Physical therapy ultrasound system FDA UDI
- Device Name
- AUTOSOUND 9.6 FDA UDI
- Model / Reference
- 400-021 FDA UDI
- Description
- AUTOSOUND 9.6 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00852515007049 FDA UDI
- FDA Product Code
- IMG FDA UDIIMI FDA UDIIPF FDA UDIGZJ FDA UDILIH FDA UDI
- GMDN Term
- Physical therapy ultrasound system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5860 FDA UDI890.5300 FDA UDI890.5850 FDA UDI882.5890 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
No
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
Category: Physical therapy ultrasound system
Autosound by Compass Health Brands Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Physical therapy ultrasound system.
- CHATTANOOGA — DJO, LLC · Class II
- PainShield MD Supplies Kit — NANOVIBRONIX INC. · Class II
- Sonicator 719 — METTLER ELECTRONICS CORP. · Class II
- Sonopuls 190 — Enraf-Nonius B.V. · Class II
- JAS Pulse 3MHz — AXIOSONIC, LLC · Class II
- Sonopuls 190 — Enraf-Nonius B.V. · Class II
- JAS Pulse — AXIOSONIC, LLC · Class II
- CHATTANOOGA — DJO, LLC · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Compass Health Brands Corp.
Sources (1)
- FDA UDI 9fba0a21-d614-4c65-9213-92b209da9b4d 34 fields · synced May 30, 2026