AccessGUDID - DEVICE: OrthoCor Medical (00851979007510)

GUDID

Device Identifier (DI) Information

Brand Name: OrthoCor Medical
Version or Model: Activ8 Ankle
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Caerus Corp.

Primary DI Number: 00851979007510
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 021776723 *Terms of Use

Device Description: The Activ8 family of devices are portable, compact, lightweight, non-invasive system designed to deliver transcutaneous pulsed electromagnetic field (PEMF) stimulation therapy and electronic heat for adjunctive use in the temporary relief of pain, such as pain associated with over-exertion, strains, sprains, and arthritis.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
35169	Hand-held deep-tissue electromagnetic stimulator	A battery-powered, hand-held device designed to apply an electromagnetic (EM) field to body deep tissues to help reduce pain associated with musculoskeletal/neurological disorders (e.g., arthritis, sciatica) and/or to treat soft-tissue wounds and injuries with no production of a therapeutic deep heat. It is a self-contained electronic unit with controls intended to be applied to the body to emit short-time pulsed, radio-frequency energy [pulsed electromagnetic fields (PEMF)] to tissues at a level below the patient's heat sensory perception threshold. It is not intended to apply an electric current directly to the body. The device is intended to be used in clinical and home settings.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ILX	Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat
IRT	Pad, Heating, Powered

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K241395	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 07608d30-9616-45ca-9034-4aea140c3515
Public Version Date: March 18, 2025
Public Version Number: 1
DI Record Publish Date: March 10, 2025