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K Number
K964437
Device Name
GB-1002 TENS WITH MASSAGE
Manufacturer
SKYLARK DEVICE CO., LTD.
Date Cleared
1998-08-14

(647 days)

Product Code
GZJ
Regulation Number
882.5890
Type
Traditional
Panel
NE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

TRANSCUTANEOUS ELECTRICAL NERVE STIMULATION (TENS) DE VICES ARE USED FOR THE SYMPTOMATIC RELIEF AND MANAGEMENT OF CHRONIC (I ONG TERM) INTRACTABLE PAIN AND AS AN ADJUNCTIVE TREATMENT IN THE MANAGEMENT OF POST SURGICAL AND POST TRAUMATIC ACUTE PAIN PROBLEMS. A THERAPEUTIC VIBRATOR IS INTENDED FOR RELAXING MUSCLES AND RELIEVING MINOR MUSCLE ACTIES AND PAINS.

Device Description

GB-1002 TENS WITH VIBRATOR

AI/ML Overview

The provided document is a 510(k) clearance letter from the FDA for the GB-1002 Tens with Vibrator device. It states that the device is substantially equivalent to a predicate device already on the market.

However, this document does not contain any information regarding acceptance criteria, device performance, or any studies conducted to prove device performance.

Therefore, I cannot provide the requested information. The document focuses solely on the regulatory clearance process based on substantial equivalence, not on specific performance metrics or clinical study results.

§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.

(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).