Identity
- Trade Name
- DualPulse Compact FDA UDI
- Generic Name
- Physical therapy transcutaneous neuromuscular electrical stimulation system FDA UDI
- Device Name
- The DualPuse Compact delivers electric pulse generated to the user’s body areas through the electrodes. The device has two program modes of different pulse frequencies, covering TENS and PMS/NMES. FDA UDI
- Model / Reference
- DPC FDA UDI
- Description
- The DualPuse Compact delivers electric pulse generated to the user’s body areas through the electrodes. The device has two program modes of different pulse frequencies, covering TENS and PMS/NMES. FDA UDI
Identifiers
- Catalog Number
- DPC FDA UDI
- Primary DI / UDI-DI
- 00810113683379 FDA UDI
- FDA Product Code
- NGX FDA UDINUH FDA UDINYN FDA UDIGZJ FDA UDIIPF FDA UDI
- GMDN Term
- Physical therapy transcutaneous neuromuscular electrical stimulation system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5850 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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Physical therapy transcutaneous neuromuscular electrical stimulation system
DualPulse Compact by Manamed Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Physical therapy transcutaneous neuromuscular electrical stimulation system.
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- Therapist’s Choice® TENS2N1 Combo — CLINICAL HEALTH SERVICES, INC. · Class II
- iSelfCare — HEALTHMATE INTERNATIONAL, LLC · Class II
- JMOON — Shenzhen Ulike Smart Electronics Co., Ltd. · Class II
- Belifu — Hong Qiangxing (Shenzhen) Electronics Limited · 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 |
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Manufacturer
- Manufacturer
- Manamed Llc
Sources (1)
- FDA UDI 7e2583ad-1510-43d1-9080-e1af6616f48d 35 fields · synced Jun 8, 2026