Identity
- Trade Name
- MPO FDA UDI
- Generic Name
- Physical therapy transcutaneous neuromuscular electrical stimulation system FDA UDI
- Device Name
- TENS 3000 (Medical Products FDA UDI
- Model / Reference
- DT3089 FDA UDI
- Description
- TENS 3000 (Medical Products FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00092237612873 FDA UDI
- 510(k) Number
- K102014 FDA UDI
- FDA Product Code
- GZJ FDA UDI
- GMDN Term
- Physical therapy transcutaneous neuromuscular electrical stimulation system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5890 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
Yes
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 transcutaneous neuromuscular electrical stimulation system
Mpo by Compass Health Brands Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
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- JMOON — Shenzhen Ulike Smart Electronics Co., Ltd. · Class II
- Belifu — Hong Qiangxing (Shenzhen) Electronics Limited · Class II
Cleared under the same submission
K102014 also covers:
- Analgesic — COMPASS HEALTH BRANDS CORP.
- Direct Supply — COMPASS HEALTH BRANDS CORP.
- LG Med Supply — COMPASS HEALTH BRANDS CORP.
- Reliable Medical — COMPASS HEALTH BRANDS CORP.
- TENS 3000 — COMPASS HEALTH BRANDS CORP.
- Venti TENS — COMPASS HEALTH BRANDS CORP.
- TENS 3000 — Emsi
- TENS 8000 — Emsi
- TMR-ELTH-8500 — Emsi
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 53019d51-1e2a-4656-8510-d5688c4cda32 35 fields · synced Jun 8, 2026