Identity
- Trade Name
- PROFILE EMS FDA UDI
- Generic Name
- Physical therapy ultrasound/neuromuscular stimulation system FDA UDI
- Device Name
- The PROFILE EMS is a symmetrical biphasic neuromuscular electronic stimulator intended for medical purposes, which repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area. It is indicated for the following: - Prevention or retardation of muscle disuse atrophy; - Relaxation of muscle spasm; - Muscle reeducation; - Maintaining and increasing the range of motion; - Increasing local blood circulation; - Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis. FDA UDI
- Model / Reference
- EM-PROFILE_EMS FDA UDI
- Description
- The PROFILE EMS is a symmetrical biphasic neuromuscular electronic stimulator intended for medical purposes, which repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area. It is indicated for the following: - Prevention or retardation of muscle disuse atrophy; - Relaxation of muscle spasm; - Muscle reeducation; - Maintaining and increasing the range of motion; - Increasing local blood circulation; - Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060079210347 FDA UDI
- FDA Product Code
- IPF FDA UDI
- GMDN Term
- Physical therapy ultrasound/neuromuscular stimulation system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5850 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/neuromuscular stimulation system
Profile Ems by Body Clock Health Care, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Physical therapy ultrasound/neuromuscular stimulation system.
- PowerDot — ZMI Electronics Ltd. · Class II
- Ultratone — ULTRATONE SCIENTIFIC INSTRUMENTS LIMITED · Class II
- CHATTANOOGA — DJO, LLC · Class II
- CS6101-3 Interferential Stimulator — Control Solutions, Inc. · Class II
- Johari Digital Healthcare Limited — SYRMA JOHARI MEDTECH LIMITED · Class II
- Sonicator Plus 992, 2 channel — METTLER ELECTRONICS CORP. · Class II
- Sonicator Plus 940, 4 channel — METTLER ELECTRONICS CORP. · Class II
- PowerDot — ZMI Electronics Ltd. · 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
- Body Clock Health Care, Ltd.
Sources (1)
- FDA UDI eb2ba8e6-657d-449e-9eec-2e04fd559b7f 33 fields · synced May 31, 2026