Identity
- Trade Name
- KDY-ST FDA UDI
- Generic Name
- Joint/spinal manipulator, electronic FDA UDI
- Device Name
- Adjusting instrument FDA UDI
- Model / Reference
- SA-201 FDA UDI
- Description
- Adjusting instrument FDA UDI
Identifiers
- Primary DI / UDI-DI
- B733KDYST0 FDA UDI
- 510(k) Number
- K962239 FDA UDI
- FDA Product Code
- LXM FDA UDI
- GMDN Term
- Joint/spinal manipulator, electronic 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Joint/spinal manipulator, electronic
Kdy-St by Sigma Instruments, Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Joint/spinal manipulator, electronic.
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- Prosports 360 — Neuromechanical Innovations, L.L.C. · U
- Activator Methods — ACTIVATOR METHODS INTERNATIONAL LTD.
- Impulse Adjusting Instrument — Neuromechanical Innovations, L.L.C. · U
- PulStar — SENSE TECHNOLOGY, INC. · U
- Prosoft SRT — Neuromechanical Innovations, L.L.C. · U
Cleared under the same submission
K962239 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
- Sigma Instruments, Inc.
Sources (1)
- FDA UDI 89d84b68-cc8a-4141-aa4d-2c2653d3351e 34 fields · synced May 30, 2026