Identity
- Trade Name
- CHATTANOOGA FDA UDI
- Generic Name
- Physical therapy transcutaneous neuromuscular electrical stimulation system FDA UDI
- Device Name
- COLPAC EYE PACKED BULK FDA UDI
- Model / Reference
- 1510-1 FDA UDI
- Description
- COLPAC EYE PACKED BULK FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00190446164937 FDA UDI
- FDA Product Code
- IRT FDA UDI
- GMDN Term
- Physical therapy transcutaneous neuromuscular electrical stimulation system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5740 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
No
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Physical therapy transcutaneous neuromuscular electrical stimulation system
Chattanooga by Djo, 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.
- RS-4s Muscle Stimulator System (R) — Rs Medical · Class II
- BodyMed — BOXOUT, LLC · Class II
- veicomtech — Guangzhou Huakai Electronic Technology Co., Ltd. · Class II
- 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
- INNOVO — Atlantic Therapeutics, 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
- Djo, Llc
Sources (1)
- FDA UDI a7c2bb21-ec4f-45c1-8a99-bab9ea099916 33 fields · synced May 31, 2026