ActivForce 2

Basic Information

• Brand Name: ActivForce 2
• Primary DI: 00850004866184
• Version / Model: Activ5-M
• Company Name: ActivBody, Inc.
• Labeler DUNS: 079380877
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-09-03
• Public Version: 2
• Public Version Date: 2026-03-11
• Public Version Status: Update
• Public Device Record Key: 5ead61f9-ba17-4bc9-8b78-423de13792ed
• Distribution End Date: 2032-12-31

Device Description

Wireless digital dynamometer and goniometer.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LBB	Dynamometer, Ac-Powered	Orthopedic	888.1240	2
KQX	Goniometer, Ac-Powered	Orthopedic	888.1500	1

GMDN Terms

Code	Name	Definition	Implantable	Status
33652	Electronic goniometer/kinesiology sensor	A small electronic device designed to be fastened to a body part (e.g., a patient worn goniometer-, accelerometer-, or gyroscope-sensor), or hand-held by a clinician (e.g., goniometer), to evaluate a patient’s range of motion/movement of individual joints/limbs/spine; it is used in a clinical setting typically before/after a medical/surgical intervention, or to assess degree of physical fitness. Acquired data may be transferred to a computing device/software for recording/display and analysis.	No	Active
61672	Back/leg/chest dynamometer, electronic	A portable, hand-held, electrically-powered, digital instrument designed to assess neuromuscular function by measuring the force or power exerted by the back, chest, and/or leg muscles during flexion. It includes a force gauge, which may be attached to a handle or strap, to assess force generated during a variety of movements (e.g., leg abduction, lifting) and/or force required to be exerted by a clinician to overcome a patient’s resistance (break test techniques). Is typically used to test or control a patient's muscle strength as part of a rehabilitation program.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850004866184	GS1