DIGITAL TENS ONE CHANNEL

GUDID 04716770925608

DIGITAL TENS ONE CHANNEL

BESMED HEALTH BUSINESS CORP.

Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system

• Primary Device ID: 04716770925608
• NIH Device Record Key: 95875c2c-595c-4e19-b976-853d3de131ad
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DIGITAL TENS ONE CHANNEL
• Version Model Number: BE-92560
• Company DUNS: 658023775
• Company Name: BESMED HEALTH BUSINESS CORP.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04716770925608 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K031375

FDA Product Code

• IPF: Stimulator, Muscle, Powered

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-10-23
• Device Publish Date: 2017-12-15

Devices Manufactured by BESMED HEALTH BUSINESS CORP.

• 04716770834221 - ICU gas sampling pack: 2022-08-16 OEM ref: C05096-01-11
• 04716770834238 - ICU gas sampling pack with flowmeter: 2022-08-16 OEM ref: C05096-02-11
• 04716770144306 - Straight Connector 15F/22M, 15M W/PORT & CAP: 2021-01-15
• 04716770857398 - FLOW SENSOR, ADULT: 2021-01-15
• 04716770790015 - Elbow connetor 18MM ID for nebulizer: 2020-03-23 Elbow connetor 18MM ID for nebulizer
• 04716770791043 - MOUTH PIECE (OD:18mm,22mm): 2020-03-23 MOUTH PIECE (OD:18mm,22mm)
• 04716770791081 - MOUTH PIECE(OD:22mm): 2020-03-23 MOUTH PIECE(OD:22mm)
• 04716770791098 - MOUTH PIECE (ID:18mm, OD:19.5mm): 2020-03-23 MOUTH PIECE (ID:18mm, OD:19.5mm)