Digital Grip/Pinch Strength Metor
510(k) K850697
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK850697 | Date14 May 1985 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- LBB
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.1240
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
This device is a Dynamometer, Ac-Powered, classified under FDA Product Code LBB. It measures grip and pinch strength digitally, providing quantitative assessments of hand and forearm muscle function. Designed for orthopedic and neurological evaluations, it aids in clinical assessments of muscle strength and functional capacity.
The Digital Grip/Pinch Strength Meter is supplied as a reusable, non-sterile device intended for use in clinical or rehabilitation settings. It operates on alternating current (AC) power and is regulated under FDA regulation 888.1240, with a clearance date of May 14, 1985. No MRI safety information is provided, and storage conditions are not specified in the available data.
Other devices from Chattanooga Group, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Digital Grip/Pinch Strength Meter used for?
The Digital Grip/Pinch Strength Meter is designed to measure grip and pinch strength digitally, providing objective assessments of hand and forearm muscle function. Clinicians use it in orthopedic and neurological evaluations to gauge muscle strength and functional capacity, helping to monitor recovery or diagnose conditions affecting hand performance.
Is the Digital Grip/Pinch Strength Meter reusable or single-use?
This device is supplied as a reusable dynamometer, meaning it is intended for repeated use in clinical or rehabilitation settings. It is not classified as a single-use item, though proper cleaning and maintenance are required to ensure accurate measurements and prevent cross-contamination between patients.
What power source does the Digital Grip/Pinch Strength Meter require?
The device operates on alternating current (AC) power, as specified in its design. It is not battery-powered or designed for portable use without an external power supply.
Does the Digital Grip/Pinch Strength Meter have any sterility requirements?
The device is non-sterile and intended for use in clinical or rehabilitation settings where sterility is not a primary concern for the device itself. However, proper hygiene practices, such as cleaning the device between uses, should be followed to maintain patient safety and measurement accuracy.
What regulatory approval does the Digital Grip/Pinch Strength Meter hold?
The device holds FDA clearance under the 510(k) pathway, specifically classified under FDA Product Code LBB (Dynamometers). It was granted clearance on May 14, 1985, and is regulated under FDA regulation 888.1240. No additional regulatory details beyond this are provided in the available data.