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ActaStim-S

FDA UDI

Class II (US FDA UDI)

by Theragen, Inc.

Identity

Trade Name
ActaStim-S FDA UDI
Generic Name
Patient-worn bone growth electromagnetic stimulator FDA UDI
Device Name
ActaStim-S Spine Fusion Stimulator - Leadwire, Short FDA UDI
Model / Reference
1101-0006 FDA UDI
Description
ActaStim-S Spine Fusion Stimulator - Leadwire, Short FDA UDI

Identifiers

Catalog Number
1101-0006 FDA UDI
Primary DI / UDI-DI
00850372007196 FDA UDI
PMA Number
P190030 FDA UDI
FDA Product Code
LOF FDA UDI
GMDN Term
Patient-worn bone growth electromagnetic stimulator FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
890.5870 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

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Patient-worn bone growth electromagnetic stimulator

ActaStim-S by Theragen, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Patient-worn bone growth electromagnetic stimulator.

Cleared under the same submission

P190030 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Theragen, Inc.

Sources (1)

  • FDA UDI e2a15fc4-9d63-4eb3-a528-24b1db1bc4d2 37 fields · synced Jun 8, 2026