Identity
- Trade Name
- Original CAT FDA UDI
- Generic Name
- Joint/spinal manipulator, mechanical FDA UDI
- Device Name
- A hand-held, non-powered mechanical device intended to be used by a healthcare professional for the adjustment, mobilization, or manipulation of the joints of the spine and/or extremities. This is a reusable, non-invasive, non-surgical, non-sterile, transient. FDA UDI
- Model / Reference
- CT001 FDA UDI
- Description
- A hand-held, non-powered mechanical device intended to be used by a healthcare professional for the adjustment, mobilization, or manipulation of the joints of the spine and/or extremities. This is a reusable, non-invasive, non-surgical, non-sterile, transient. FDA UDI
Identifiers
- Primary DI / UDI-DI
- G041CT0010 FDA UDI
- 510(k) Number
- K974376 FDA UDI
- FDA Product Code
- LXM FDA UDI
- GMDN Term
- Joint/spinal manipulator, mechanical FDA UDI
Classification
- Device Class
- U 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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Joint/spinal manipulator, mechanical
Original CAT by J-Tech Medical, Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K974376 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 U | Pending data |
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Manufacturer
- Manufacturer
- J-Tech Medical, Inc.
Sources (1)
- FDA UDI cfc57eb1-64d8-483b-bde1-0bdc07d82eba 35 fields · synced May 30, 2026