Identity
- Trade Name
- Fit Relief FDA UDI
- Generic Name
- Psychiatric-therapy/physical-therapy transcutaneous electrical stimulation system FDA UDI
- Device Name
- Fit Relief Device FDA UDI
- Model / Reference
- 6404 FDA UDI
- Description
- Fit Relief Device FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850018806800 FDA UDI
- 510(k) Number
- K191938 FDA UDI
- FDA Product Code
- NGX FDA UDI
- GMDN Term
- Psychiatric-therapy/physical-therapy transcutaneous electrical 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
No
FDA UDI
Over-the-Counter
Yes
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
No
FDA UDI
Category: Psychiatric-therapy/physical-therapy transcutaneous electrical stimulation system
Fit Relief by Heat In A Click Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Psychiatric-therapy/physical-therapy transcutaneous electrical stimulation system.
- Alpha-Stim 100 — Electromedical Products International, Inc.
- Alpha-Stim M — Electromedical Products International, Inc.
- Alpha-Stim M — Electromedical Products International, Inc.
- Alpha-Stim PPM — Electromedical Products International, Inc.
- TruDenta M — Electromedical Products International, Inc.
- Electronic Pulse Stimulator — Shenzhen Jumper Medical Equipment Co., Ltd. · Class II
- Lumina NRG — HEAT IN A CLICK LLC · Class II
Cleared under the same submission
K191938 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 |
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Manufacturer
- Manufacturer
- Heat In A Click Llc
Sources (1)
- FDA UDI 7af9837e-cc52-47d4-869a-ac5553196613 34 fields · synced May 29, 2026