Identity
- Trade Name
- Silberg T.P.S. FDA UDI
- Generic Name
- Physical therapy ultrasound system FDA UDI
- Device Name
- Silberg Tissue Preparation System FDA UDI
- Model / Reference
- ME 800 FDA UDI
- Description
- Silberg Tissue Preparation System FDA UDI
Identifiers
- Catalog Number
- ME 800 FDA UDI
- Primary DI / UDI-DI
- 00816864020432 FDA UDI
- 510(k) Number
- K023083 FDA UDI
- FDA Product Code
- IMG FDA UDIFRN FDA UDI
- GMDN Term
- Physical therapy ultrasound system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5860 FDA UDI880.5725 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
- Weight — 10 Pound FDA UDI
Category: Physical therapy ultrasound system
Silberg T.P.S. by Mettler Electronics 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
- Sonopuls 190 — Enraf-Nonius B.V. · Class II
- JAS Pulse 3MHz — AXIOSONIC, LLC · Class II
- TheraTouch UX2 — COMPASS HEALTH BRANDS CORP. · Class II
- AUTOSOUND — COMPASS HEALTH BRANDS CORP. · Class II
- Sonopuls 190 — Enraf-Nonius B.V. · Class II
- JAS Pulse — AXIOSONIC, 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
- Mettler Electronics Corp.
Sources (1)
- FDA UDI 11fa65fc-2cf3-49e0-8b3a-d9e2c23e31a4 38 fields · synced Jun 8, 2026