TPLC - Total Product Life Cycle

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Device	stimulator, bone growth, non-invasive
Definition	A non-invasive bone growth stimulator is a prescription device that provides stimulation through electrical, magnetic, or ultrasonic fields. The device is intended to be used externally to promote osteogenesis as an adjunct to primary treatments for fracture fixation and spinal fusion or as a treatment for established nonunions or failed fusions. Please reference: www.federalregister.gov/documents/2026/04/16/2026-07366/physical-medicine-devices-reclassification-of-non-invasive-bone-growth-stimulators.
Product Code	LOF
Regulation Number	890.5870
Device Class	2

Premarket Approvals (PMA)
2021	2022	2023	2024	2025	2026
2	7	5	5	2	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	524	524
Patient-Device Incompatibility	511	512
Insufficient Information	346	346
Off-Label Use	22	22
Patient Device Interaction Problem	7	7
Unintended Electrical Shock	3	3
Overheating of Device	3	3
Device-Device Incompatibility	2	2
Output Problem	2	2
Therapeutic or Diagnostic Output Failure	2	2
Inappropriate/Inadequate Shock/Stimulation	2	2
Component Incompatible	2	2
Unintended Movement	1	1
Defective Component	1	1
Defective Device	1	1
Measurement System Incompatibility	1	1
Use of Device Problem	1	1
Material Deformation	1	1
Unexpected Therapeutic Results	1	1
Inadequate or Insufficient Training	1	1
Temperature Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pain	547	547
Skin Inflammation/ Irritation	265	265
Blister	85	85
Rash	77	78
Itching Sensation	75	76
Swelling/ Edema	50	50
Burn(s)	46	46
Headache	31	31
Cramp(s) /Muscle Spasm(s)	30	30
Hypersensitivity/Allergic reaction	29	30
Burning Sensation	29	29
Shock	22	22
Discomfort	22	22
Numbness	21	21
Paresthesia	16	16
Unspecified Infection	13	13
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	11	11
Skin Burning Sensation	10	10
Dizziness	9	9
Neuropathy	8	8
Nausea	8	8
Erythema	8	9
High Blood Pressure/ Hypertension	7	7
Bruise/Contusion	6	6
Neck Pain	6	6
Muscle Weakness	6	6
Irritability	5	5
Chest Pain	5	5
No Clinical Signs, Symptoms or Conditions	5	5
Skin Discoloration	4	4
Pressure Sores	4	4
Abrasion	3	3
Ambulation Difficulties	3	3
Non-union Bone Fracture	3	3
Tachycardia	3	3
Inflammation	3	3
Convulsion/Seizure	3	3
Electric Shock	3	3
Insufficient Information	3	3
Unspecified Heart Problem	3	3
Vertigo	3	3
Diarrhea	3	3
Arrhythmia	2	2
Nodule	2	2
Contact Dermatitis	2	3
Shaking/Tremors	2	2
Neck Stiffness	2	2
Skin Tears	2	2
Fatigue	2	2
Bacterial Infection	2	2