PURE ENRICHMENT

GUDID B311PETNEMHT1

BEAR DOWN CONSULTING

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: B311PETNEMHT1
• NIH Device Record Key: 2ab9d5d9-0f24-47a3-8cfd-11cfa5e34a07
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PURE ENRICHMENT
• Version Model Number: PETNEMHT
• Company DUNS: 040869867
• Company Name: BEAR DOWN CONSULTING
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B311PETNEMHT0 [Primary]
HIBCC	B311PETNEMHT1 [Package]; Contains: B311PETNEMHT0; Package: MASTER CARTON [32 Units]; In Commercial Distribution
HIBCC	B311PETNEMHT2 [Package]; Contains: B311PETNEMHT0; Package: INNER CARTON [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221384

FDA Product Code

• NUH: Stimulator, Nerve, Transcutaneous, Over-The-Counter

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-08-22
• Device Publish Date: 2022-08-12

On-Brand Devices [PURE ENRICHMENT]

• 00853975005651: neck heating pad
• 00853975005644: heating pad
• 00853975005613: neck heating pad
• 00853975005606: heating pad
• 00853975005583: Heating and cooling pad
• B311PETENSPAD5: ELECTRODE PADS
• B311PEPULSEPRO1: TENS UNIT
• B311PEPULSEDUO0: TENS & EMS UNIT
• B311PEPULSE1: TENS UNIT
• B311PEPROPAD0: PACK OF ELECTRODES
• B311PEPROBELT0: THERAPY BELT FOR BACK.
• B311PEPADBFLY1: LARGE ELECTRODE PAD
• B311PEFETDPL1: Fetal Doppler. Used to hear heart rate sounds.
• B311PEBRPUMP1: Dual electric breast pump.
• 00817387022545: PELUXWAV-S
• 00817387022538: PEPNTLUX-A
• 00817387022521: PEDESHBN
• 00817387022514: PEHPALM-A
• 00817387022507: PEHPGTREL
• 00817387022491: PEHPNVGR
• B311PEPEAK1: Massager, therapeutic, electric
• 00817387022477: PEWTPLRG-L
• 00817387022460: PEWTPSML-L
• 00817387020800: heating pad
• 00817387020732: Heating Pad for Back and Neck
• 00817387020725: heating pad
• 00817387020718: heating pad
• 00817387020688: heating and cooling lumbar pad
• 00817387020596: heating pad
• 00817387020206: Heating pad
• 00817387024075: Weighted Heating Pad
• 00817387024273: Weighted Neck Heating Pad
• 00817387025997: PEHT24RT-G
• 00817387025010: PEHPWD2-G
• 00817387026147: PECLPBK-MG
• 00817387026130: PEWDVAL-AT
• 00817387025829: PEHPVAL-RB
• 00817387025812: PEHPAD24-ZG
• 00817387026154: PECLPNE-MG
• 00817387026512: PECERDIA
• 00817387026505: PELAULVS
• 00817387026574: PEWDVAL-G
• 00817387022637: PEHTWGHT-G
• 00817387026888: PEWTVAL-MT
• 00817387022187: PEHPWIDE-SG
• 00817387022170: PEHPBACK-SG
• 00817387027465: PEHPBACK-CG
• B311PEPULSERT0: PEPULSE-RT
• B311PETNEMPD51: Wired TENS+EMS+HEAT Replacement Gel Pads
• B311PETNEMPD21: Wired TENS+EMS+HEAT Replacement Gel Pads 2 sets