Identity
- Trade Name
- InterX FDA UDI
- Generic Name
- Physical therapy transcutaneous neuromuscular electrical stimulation system FDA UDI
- Device Name
- The InterX® Personal Sport provides you with a simple non-drug option for the pain related to acute or chronic injuries. Treatment can be prescribed independently or used in conjunction with other therapies to manage injuries through the recovery process. Available to individuals as a home use product or as a support during treatment with the InterX® Professional Sport model, the InterX® Personal Sport provides simple and effective treatment applications for sports and acute injuries, minor aches and pains, sprains and strains, non-complex chronic pain, general back, shoulder, and neck conditions, aggravated joint pain, muscle spasm, and hematoma (bruising/swelling). FDA UDI
- Model / Reference
- Personal Sport FDA UDI
- Description
- The InterX® Personal Sport provides you with a simple non-drug option for the pain related to acute or chronic injuries. Treatment can be prescribed independently or used in conjunction with other therapies to manage injuries through the recovery process. Available to individuals as a home use product or as a support during treatment with the InterX® Professional Sport model, the InterX® Personal Sport provides simple and effective treatment applications for sports and acute injuries, minor aches and pains, sprains and strains, non-complex chronic pain, general back, shoulder, and neck conditions, aggravated joint pain, muscle spasm, and hematoma (bruising/swelling). FDA UDI
Identifiers
- Catalog Number
- 1150-001 FDA UDI
- Primary DI / UDI-DI
- 00851894007039 FDA UDI
- 510(k) Number
- K042912 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
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
Dimensions & Sizes
- Size
- Weight — 185 Gram FDA UDIHeight — 43 Millimeter FDA UDIWidth — 52 Millimeter FDA UDILength — 215 Millimeter FDA UDI
Category: Physical therapy transcutaneous neuromuscular electrical stimulation system
InterX by Htk Enterprises, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Physical therapy transcutaneous neuromuscular electrical stimulation system.
- COMPEX — DJO, LLC · Class II
- 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
Cleared under the same submission
K042912 also covers:
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
- Htk Enterprises, Inc.
Sources (1)
- FDA UDI 43cf1157-52eb-45ef-9197-251fed6c52f5 38 fields · synced May 30, 2026