Identity
- Trade Name
- Roscoe Medical FDA UDI
- Generic Name
- Physical therapy ultrasound system FDA UDI
- Device Name
- SoundCare Plus - Wand, 5 cm FDA UDI
- Model / Reference
- DQ9275W5 FDA UDI
- Description
- SoundCare Plus - Wand, 5 cm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00092237618226 FDA UDI
- 510(k) Number
- K120217 FDA UDI
- FDA Product Code
- IMG FDA UDI
- GMDN Term
- Physical therapy ultrasound system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5860 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
No
FDA UDI
Category: Physical therapy ultrasound system
Roscoe Medical by Compass Health Brands Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K120217 also covers:
- Direct Supply — COMPASS HEALTH BRANDS CORP.
- Direct Supply — COMPASS HEALTH BRANDS CORP.
- Direct Supply — COMPASS HEALTH BRANDS CORP.
- Richmar TheraTouch — COMPASS HEALTH BRANDS CORP.
- Richmar TheraTouch — COMPASS HEALTH BRANDS CORP.
- Roscoe Medical — COMPASS HEALTH BRANDS CORP.
- Roscoe Medical — COMPASS HEALTH BRANDS CORP.
- Roscoe Medical — COMPASS HEALTH BRANDS CORP.
- Roscoe Medical — COMPASS HEALTH BRANDS CORP.
- Roscoe Medical — COMPASS HEALTH BRANDS CORP.
- TheraTouch — COMPASS HEALTH BRANDS 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Compass Health Brands Corp.
Sources (1)
- FDA UDI 8cd26c0c-96f6-42fe-81c6-abae33fa2fa6 35 fields · synced Jun 8, 2026