Identity
- Trade Name
- Myotrac Infiniti Encoder FDA UDI
- Generic Name
- Physical therapy transcutaneous neuromuscular electrical stimulation system FDA UDI
- Model / Reference
- SA9800 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07540191000104 FDA UDI
- FDA Product Code
- IPF FDA UDIKPI FDA UDIHCC 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 UDI876.5320 FDA UDI882.5050 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Physical therapy transcutaneous neuromuscular electrical stimulation systemPsychophysiological biofeedback systemPerineal orifice incontinence-control electrical stimulation system, professional
Myotrac Infiniti Encoder by Thought Technology Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Perineal orifice incontinence-control electrical stimulation system, professional.
- Pathway — PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE · Class II
- Pathway — PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE · Class II
- Vaginal Stim Sensor — Thought Technology Ltd. · Class II
- Anal Stim Probe — Thought Technology Ltd. · Class II
- MyOnyx Mobile App — Thought Technology Ltd. · Class II
- MyOnyx — Thought Technology Ltd. · Class II
Cleared under the same submission
K053266 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
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
- Thought Technology Ltd.
Sources (1)
- FDA UDI 568fdae2-122b-47e3-8be5-abf46d281a76 33 fields · synced Jun 8, 2026