HWZ Forums

Login Register FAQ Mark Forums Read

Apple Watch Series 4

Like Tree274Likes
Reply
 
LinkBack Thread Tools
Old 07-10-2018, 01:43 AM   #1516
Supremacy Member
 
Join Date: Dec 2004
Posts: 8,708
No FDA isn't the most stringent by a long way. The ECG function on the Apple watch 4 only received FDA 'clearance' which is a fast track procedure to allow devices which cannot be used for any real diagnosis to be marketed. FDA 'approval' is a much longer process and that one is tough.

The HSA doesn't even automatically approve devices which have been through the full FDA approval process, although it does take that into account, with just FDA clearance .. doesn't mean much.

It's down to Apple to submit it and HSA to decide if it's a class A device, which should be registered very easily, or a class B one which will require a more thorough process. I hope the feature is approved here but I'm not expecting it soon.
For those who are not familiar with FDA clearance vs approved. Why is clearance instead of approved? The ECG function on Apple Watch is determined to be substantially equivalent to (similar) another legally marketed device (typical ECG devices sold in the market). No approval is required because the Apple Watch wonít be classified as a class III device. I think the Apple Watch is never meant to be a diagnostic device but rather a monitoring devices. [ie. doctor wonít use reading in Apple Watch to say you have heart problem but rather use this as a monitoring tool to monitor patients diagnose with heart problem]. FYI, Apple Watch ECG function will never be a class A device. Maybe a class B or C (HSA classification: https://www.hsa.gov.sg/content/hsa/en/Health_Products_Regulation/Consumer_Information/Consumer_Guides/Medical_Devices.html)

https://www.fda.gov/medicaldevices/resourcesforyou/consumers/default.htm

Extracted from FDA website

What is the difference between Cleared and Approved?

In order for medical devices to be legally marketed (sold) in the United States, they are required to be cleared or approved by the FDA unless it is 510(k) exempt.
Cleared medical devices: These medical devices are ones that FDA has determined to be substantially equivalent to (similar) another legally marketed device. A premarket notification submission is referred to as a 510(k) and must be submitted to FDA to review and provide clearance.

Approved medical devices: Approved medical devices are those devices that the FDA has approved a premarket approval (PMA) application or a Humanitarian Device Exemption (HDE) application. This review and approval process is for Class III medical devices (the ones with the highest risk) and involves a more rigorous review than the 510(k) review process.
alvino likes this.
htngwilliam is offline   Reply With Quote
Old 07-10-2018, 07:52 AM   #1517
Master Member
 
NiShiZhu's Avatar
 
Join Date: Jan 2005
Posts: 4,824
Is this at the Apple Store? Because I didnít think they will let you try the Hermes one.
Itís my own Hermes watch bought from Apple Orchard. Not demo set.
They actually let me try all types of Hermes straps before I buy.
I also tried the gold ss to compare. The staff there quite friendly.
As I have stated previously in my post, ss gold was initially my first choice until when I realised how gorgeous the Hermes one look on my wrist (at least to me, lol). Thatís when I immediately cancel the ss gold.
NiShiZhu is offline   Reply With Quote
Old 07-10-2018, 07:56 AM   #1518
Master Member
 
NiShiZhu's Avatar
 
Join Date: Jan 2005
Posts: 4,824
I was waiting and still have a gold SS shipment for 18 Oct. However, as I pointed out in my earlier post, I am not slowing being swayed to go with the Hermes silver SS ones as I have tried a few leather / metal straps and I think they go best with silver SS.

I'm deciding if I should pay ~ $700 more to go with the Hermes ones. Is it worth it for the following extras:
1) Hermes watch face
2) Hermes leather strap
3) Hermes orange sport band
4) Extra 1 year of warranty
If Hermes, which strap will u go for? Just curious.
NiShiZhu is offline   Reply With Quote
Old 07-10-2018, 08:19 AM   #1519
Master Member
 
NiShiZhu's Avatar
 
Join Date: Jan 2005
Posts: 4,824


SS gold tried at Apple Orchard
__________________
I love Cooling Measures
NiShiZhu is offline   Reply With Quote
Old 07-10-2018, 09:10 AM   #1520
Member
 
Join Date: Feb 2012
Posts: 171
Anyone know what is the procedure to return the watch that I had just bought two days ago at Apple Orchard? Was excited to finally own an Apple Watch but these past few days made me realise I didn’t have much use for it
speedy94 is offline   Reply With Quote
Old 07-10-2018, 09:18 AM   #1521
Arch-Supremacy Member
 
renfred89's Avatar
 
Join Date: Nov 2007
Posts: 17,476
Anyone know what is the procedure to return the watch that I had just bought two days ago at Apple Orchard? Was excited to finally own an Apple Watch but these past few days made me realise I didnít have much use for it
you need to bring everything, the box and every single item in it, together with receipt and approach anyone wearing the apple tee shirt and inform them you wanna return the item.

they will ask you why, just tell them the reason. no reason also must fake one up.
renfred89 is offline   Reply With Quote
Old 07-10-2018, 09:20 AM   #1522
High Supremacy Member
 
Join Date: Jan 2010
Posts: 46,906

With the Hermes indigo Bleu stripe
Looks dam nice!

I am slowly growing to like the silver SS as well ! This is esp so when paired with the leather straps. Also, note that the strap lugs are typically silver SS also. As such, if you look closely on the gold SS with the leather strap, the are actually 2 tones between the gold watch and the silver lug on the strap - minor but could be a big deal to some.
Yeah, the silver SS is super good. Welcome to the SS club!

imagine theres is a knock off version of the hermes leather strap. lol
Well, genuine leather and knock-off leather is a huge difference.

Itís my own Hermes watch bought from Apple Orchard. Not demo set.
They actually let me try all types of Hermes straps before I buy.
I also tried the gold ss to compare. The staff there quite friendly.
As I have stated previously in my post, ss gold was initially my first choice until when I realised how gorgeous the Hermes one look on my wrist (at least to me, lol). Thatís when I immediately cancel the ss gold.
Nice buy for that Hermes Watch!



SS gold tried at Apple Orchard
The band makes it look ugly I feel.
__________________
Jirachi is offline   Reply With Quote
Old 07-10-2018, 09:26 AM   #1523
Arch-Supremacy Member
 
Snoweagle's Avatar
 
Join Date: Sep 2005
Posts: 17,150
My 44mm SS with white sport band as at 7+am this morning already arrived in SG with clearance completed. I suppose tomorrow should receive it.

But my wifeís 40mm gold aluminium with pink sport band still under Ďprocessingí, CC also not deducted yet.
__________________
2020 M1 MBP 13, M Mouse 2, iPhone 11 Pro Max/12 Pro Max, iPad Pro 11, Watch S6 SS, AirPods 2/Pro.
Snoweagle is online now   Reply With Quote
Old 07-10-2018, 10:00 AM   #1524
Master Member
 
Join Date: Jul 2004
Posts: 3,117
guys, if you’re looking for quality custom leather straps, do consider Jason and Sherron

Got link? Can’t find.

edit: nvm found it when using desktop, http://www.jasonsherron.com/!

Last edited by CyberMew; 07-10-2018 at 03:40 PM..
CyberMew is offline   Reply With Quote
Old 07-10-2018, 10:01 AM   #1525
Senior Member
 
wolfverine88's Avatar
 
Join Date: Aug 2010
Posts: 691
I would go for the dark brown deployment buckle



If Hermes, which strap will u go for? Just curious.
wolfverine88 is offline   Reply With Quote
Old 07-10-2018, 10:01 AM   #1526
Senior Member
 
Join Date: Oct 2005
Posts: 597


The band makes it look ugly I feel.
Iíd use that band only for sportsó imo everything else this gold watch needs another band. Also the Color in this pic is washed out, the real band is not white
klho001 is offline   Reply With Quote
Old 07-10-2018, 10:24 AM   #1527
Master Member
 
NiShiZhu's Avatar
 
Join Date: Jan 2005
Posts: 4,824
[QUOTE=wolfverine88;116900516]I would go for the dark brown deployment buckle



Haha, same here. Cos the deployment buckle seems like it wonít hurt the leather strap as much as single/double tour.
But unfortunately, it is out of my Budget.
NiShiZhu is offline   Reply With Quote
Old 07-10-2018, 10:25 AM   #1528
Master Member
 
NiShiZhu's Avatar
 
Join Date: Jan 2005
Posts: 4,824
Iíd use that band only for sportsó imo everything else this gold watch needs another band. Also the Color in this pic is washed out, the real band is not white
Its with stone sports band, not white.
It is still better to try it personally at Apple Orchard to have a more accurate gauge.

Last edited by NiShiZhu; 07-10-2018 at 11:07 AM..
NiShiZhu is offline   Reply With Quote
Old 07-10-2018, 01:24 PM   #1529
Senior Member
 
Join Date: Mar 2008
Posts: 2,338
There’s 40mm SS SB milanese avail.
Nothing else and hermes model
mackie8 is offline   Reply With Quote
Old 07-10-2018, 02:36 PM   #1530
Arch-Supremacy Member
 
StanII's Avatar
 
Join Date: Jan 2007
Posts: 14,541
Thereís 40mm SS SB milanese avail.
Nothing else and hermes model
The SB 40mm Milanese since yesterday alr though

Haven heard of gold SS restocking yet either
limpeh23 likes this.
StanII is offline   Reply With Quote
Reply
Important Forum Advisory Note
This forum is moderated by volunteer moderators who will react only to members' feedback on posts. Moderators are not employees or representatives of HWZ. Forum members and moderators are responsible for their own posts.

Please refer to our Terms of Service for more information.


Thread Tools

Posting Rules

Smilies are On
[IMG] code is On
HTML code is Off
Trackbacks are Off
Pingbacks are Off
Refbacks are On