K6-I Diagnostic System
510(k) K922456
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SN | NumberK922456 | Date9 Jun 1994 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- KZM
- Device Class
- Class II
- Regulation
- 21 CFR Part 890.1375
- Advisory Committee
- Physical Medicine
- FDA Decision
- SN
Overview
AI-generated summary, 1 Oct 2026
The K6-I Diagnostic System is a device used for muscle monitoring in the field of physical medicine. It is classified as a Class II medical device under regulation number 890.1375.
The system received FDA 510(k) clearance (K922456) on June 9, 1994, and is substantially equivalent for some indications. It is manufactured by Myo-Tronics, Inc. and assigned product code KZM.
Other devices from Myo-Tronics, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the K6-I Diagnostic System used for?
The K6-I Diagnostic System is used for muscle monitoring in the field of physical medicine, as indicated in its device description and regulatory classification under regulation number 890.1375 for muscle monitoring devices.
Who manufactures the K6-I Diagnostic System and what is its product code?
The K6-I Diagnostic System is manufactured by Myo-Tronics, Inc., and is assigned the product code KZM, which is used to identify the device in FDA regulatory records and product listings.
When did the K6-I Diagnostic System receive FDA clearance and what type was it?
The K6-I Diagnostic System received FDA 510(k) clearance on June 9, 1994, under submission number K922456, and was processed as a Traditional 510(k) with a decision of substantially equivalent for some indications.