Identity
- Trade Name
- SpineMED Decompression System FDA UDI
- Generic Name
- Programmable powered traction system FDA UDI
- Device Name
- SpineMED S200E Express Decompression System Lumbar Only FDA UDI
- Model / Reference
- S200E FDA UDI
- Description
- SpineMED S200E Express Decompression System Lumbar Only FDA UDI
Identifiers
- Primary DI / UDI-DI
- M767S200E1 FDA UDI
- 510(k) Number
- K051013 FDA UDI
- FDA Product Code
- ITH FDA UDI
- GMDN Term
- Programmable powered traction system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5900 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
Yes
FDA UDI
Category: Programmable powered traction system
SpineMED Decompression System by Universal Pain Technology Canada Inc — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Programmable powered traction system.
- Extentrac Elite — Advanced Back Technologies · Class II
- Decompression of Choice — Pivotal Health Solutions · Class II
- MTD 4000 Digital Traction — METTLER ELECTRONICS CORP. · Class II
- Decompression of Choice — Pivotal Health Solutions · Class II
- Decompression of Choice — PIVOTAL HEALTH SOLUTIONS, INC. · Class II
- Decompression of Choice — Pivotal Health Solutions · Class II
- Decompression of Choice — PIVOTAL HEALTH SOLUTIONS, INC. · Class II
- Decompression of Choice — Pivotal Health Solutions · Class II
Cleared under the same submission
K051013 also covers:
- SpineMED Decompression System — Universal Pain Technology Canada Inc
- SpineMED Decompression System — Universal Pain Technology Canada Inc
- SpineMED Decompression System — Universal Pain Technology Canada Inc
- SpineMED Decompression System — Universal Pain Technology Canada Inc
- SpineMED S200U Ultra Decompression System — Universal Pain Technology Canada Inc
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Universal Pain Technology Canada Inc
Sources (2)
- FDA UDI d597b27a-cb0f-4aca-8d08-192a4da26a6b 35 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 2, 2026