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510(k) Data Aggregation
K Number
K982828Device Name
FORTE, MODELS CPS 400 STIM, CPS 200 STIMManufacturer
Date Cleared
1998-11-06
(87 days)
Regulation Number
890.5850Type
TraditionalPanel
Physical MedicineReference & Predicate Devices
N/A
Why did this record match?
Device Name :
FORTE, MODELS CPS 400 STIM, CPS 200 STIM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
For VMS, Russian, Monophasic Hi-Volt:
- Relaxation of muscle spasms
- Prevention or retardation of disuse atrophy
- Increasing local blood circulation
- Muscle re-education
- Maintaining or increasing range of motion
- Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis
For Microcurrent. Interferential and Premodulated:
- Symptomatic relief of chronic, intractable pain
- Management of pain associated with post-traumatic or post-operative conditions
Device Description
Not Found
AI/ML Overview
The provided text is a letter from the FDA regarding a 510(k) premarket notification for several medical devices. It does not contain any information about acceptance criteria, device performance, study details, or ground truth establishment.
Therefore, I cannot provide the requested information. The document primarily confirms the substantial equivalence of the listed devices to pre-amendment devices and outlines regulatory obligations for the manufacturer.
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