Apollo Corp.

GUDID 00866595000210

Essence Whirlpool bathing system.

APOLLO CORP.

Hydrotherapy bath/tank

• Primary Device ID: 00866595000210
• NIH Device Record Key: 94217095-634c-4b4c-8b9e-2866d5f7dc48
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Apollo Corp.
• Version Model Number: ES7100
• Company DUNS: 098414501
• Company Name: APOLLO 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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
GS1	00866595000210 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K802335

FDA Product Code

• ILJ: Bath, Hydro-Massage

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-01

On-Brand Devices [Apollo Corp.]

• 00866595000234: Essence Air Spa bathing system.
• 00866595000227: Advantage Air Spa bathing system.
• 00866595000210: Essence Whirlpool bathing system.
• 00866595000203: Advantage Whirlpool bathing system.